Analytical Techniques for Estimation of Rosiglitazone

 

Prashant Rajput, Sandip Firke*

 

ABSTRACT:

Rosiglitazone is a thiazolidinedione class of antidiabetic agent utilized in the treatment of patients having Type 2 diabetes.It works as an insulin sensitizer, by binding to the peroxisome proliferator-activated receptor-γ (PPARγ) in fat cells and making the cells more responsive to insulin.The present review highlights the published analytical techniques reported so far in the literatureforthe analysis of rosiglitazone. They include various techniques likevoltammetry, spectrophotometry, high performance liquid chromatography, high performance thin layer chromatography, liquid chromatography-electrospray ionization-tandem mass spectrometry, capillary electrophoresis-electrospray ionization-mass spectrometry for their routine, impurity profiling and stability indicating determination in different pharmaceutical dosage forms.

 

 

 

INTRODUCTION:

Diabetes mellitus is the metabolic illness common over the worldwide and continuous increase in risk due to change in lifestyle and reduce of physical activity of human being^1-4. The diabetes term was firstly described by ancient Egyptian about 3000 years ago. Later on ancient Indian observed sweetness of urine and blood and rediscovered by Thomas Willis in 1675 and designated the word mellitus that is mean honey sweet.In 1776 Dobson confirmed the unnecessary sugar in bloodand also in urine. During 1936 the distinction among the Type 1 and Type 2 Diabetes was cleared.^5-9 Diabetes mainly categorizedin Type 1 and Type 2 and Gestational diabetes¹⁰.

 

The type 1diabetes is an autoimmune disorder in which the destruction of the beta cells of pancreas occurs. In type 2 diabetes, the body becomes resistant to insulin and result into impairment in the production of  insulin.^11-12 Rosiglitazone (Fig.1), 5- [[4-[2-[methyl (pyridin-2-yl)amino] ethoxy] phenyl] methyl]-1,3-thiazolidine-2,4-dione.¹³ Rosiglitazone activates the nuclear PPARγ, which expressed mainly in the faty cell to a lesser extent in muscle, liver, and other tissues. The endogenous ligand for the PPARγ receptor is postulated to be prostaglandin J2, and it appears to work by heterodimerizing with other nuclear receptors to modulate the expression of insulin-sensitive genes.^14-15 RSG is absorbed from the gastrointestinal tract by oral administration. The peak plasma concentration achieved in 1 hour. The bioavailability of RSG is 99%, metabolised by the cytochrome P450 isoenzyme CYP2C8, excreted through the urine and faeces and has the half-life of 3-4 hours. Itacts by improving the insulin sensitivity. Adverse drug reactions of RSG reported were hypoglycaemia, headache, weight gain, and anaemia, dizziness, GIT disturbances, muscle cramp, dyspnoea, paraesthesia, hypercholesterolemia and rarely angioedema. RSG mainly can cause oedema which may precipitate the heart failure.¹⁶

 

Literature survey demonstrated that there are several analytical methods have been accounted for RSG evaluation in bulk, pharmaceutical preparations and in biological fluids, involving high-performance liquid chromatography, high performance thin layer chromatography, spectrophotometry, electrochemical, capillary electrophoresis and Hyphenated techniques like LCMS, LC-ESI-MS/MS methods.

 

 

Figure 1.Rosiglitazone

 

The Reported methods describesthe analysis of RSG in bulk, pharmaceutical preparations, biological matrices and in combination with drugs like Gemfibrozil, Glimepiride, Metformin, Glipizide, Pioglitazone, Glibenclamide, Gliclazide, Sitagliptin, Glipizide, Repaglinide etc. The aim of the review is to gather the various analytical approaches for estimation of RSG for the routine analysis.

 

PHARMACOPOEIAL METHODS:

Indian Pharmacopoeia describes the estimation of RSH using High performance Liquid Chromatography. Separation was carried out by using ODS column with porus silica 5 μm and mobile phase consist of dihyrogen phosphate orthophosphate buffer pH adjust to 3.0 with dilute phosphoric acid, acetonitrile and methanol having flow rate 1.0ml/min and detected at 235 nm.¹⁷

 

 

 

ANALYTICAL METHODS

Spectrophotometric methods

Now days UV-spectrophotometry technique is broadly use in the pharmaceutical industry due to its straight forward ness and fast investigation. In literature, about eight methods were reported for estimation of RSG ^18-22 out of which, three methods are used to estimate the RSG alone and five methods are used for simultaneous estimation of RSG with other drugs. (Table 1)

 

 

Figure 2: Analytical Methods of RSG.

 

 

Figure 3: Overview of analytical methods for estimation RSG.

Table 1:Spectrophotometric methods for the analysis of RSG

Sr. No	Name of Drug	Sample Matrix	Methods	Detection (nm)	Linearity (μg/mL)	Correlation Coefficient (r2)	Reference
1	RSG and GLM	Tablet	Vierodt's method	247 and 228	2-20	0.99-1.0	18
			Absorption correction method	311.5 nm (RSG) and 228 nm (GLM)	2-20	0.99-1.0
2	RSG	Rat and Human Plasma	Zero order	247	1 -10 , 1 -17	0.9879, 0.9996	19
3	RSG and GLM	Tablet	Simultaneous Equation	318 and 238	0-30	-	20
			Two wavelength calculation method	244.8 and 257.2	0-30
			First order	252	0-30
4	RSG	Bulk and Tablet	Zero Order	248.5	2-20	0.9991	21
			Zero Order and Diazotized with sulphanillic acid	475.7	10-60	0.9996
5	RSG and GLD	Tablet	Simultaneous equation and the absorbance ratio	245 and 226	4-32 ,5-40	-	22

 

 

Figure 4: Statistics of research paper for estimation of RSG published during 2002 to 2016.

 

 

 

High-Performance liquid chromatographic method (HPLC)

To estimate the quantity of RSG in Biological samples and pharmaceutical dosage HPLC method was predominately used rather than other methods because of its sensitivity andreproducibility of results. In this review, several methods were reported for the estimation of theRSG in combination with other and alone. The (Table 2) includes the all the summeryregarding HPLC determination of RSG like sample matrices, mobile phase, stationary phase, detection wavelength, detectorsand flow rate used for separation.^23-48

 

 

Table 2. HPLC Methods for Rosiglitazone

Sr. No	Drug Name	Matrices	Detector	Detection wavelength (nm)	Mobile phase	Stationary phase	Flow rate (ml/min)	Retention time (min)	Linear range	Ref
1	RSG+ GEM	Human Plasma	Fluorescence Detector	EX250 nm and EM370 nm, EX 242 nm and EM 300 nm respectively	Acetonitrile and 30 mmol/l ammonium acetate solution (including 0.1% methanoic acid)	Macherey–Nagel Nucleodur C18(250mm x 4.6mm, 5 μm)	1.2ml/min	5.75 min, 12.62 min	5.0-751.3 ng/ml, 0.50–75.4μg /ml	23
2	RSG+MET	Tablet	UV detector	239 nm	Methanol: Phosphate buffer (pH 4) 70:30v/v	Symmetry C18 column XTerra (150 x 4.6mm, 5 μm)	0.5ml/min	5.694 min, 3.333 min	10 - 50μg/ml, 05-25μg/ml	24
3	RSG+ GLM	Human Plasma and Tablet	UV detector	235 nm	Acetonitrile:0.02 M phosphate buffer of (pH 5)60: 40v/v	Symmetry C18 column (150 mm x 4.6 mm, 5 μm)	1ml/ min	3.7 min, 4.66 min	0.10-25 μg/ml, 0.125-12.5 μg/mL	25
4	RSG+MET	Bulk And Tablet	UV-Visible detector	230 nm	Ammonium dihydrogen phosphate buffer : Acetonitrile (pH 4.5) 65:35v/v	C18 column (250 x 4.6 mm, 5μm)	1 ml/ min	7.19 min , 5.57 min	12 –32 μg/ml, 20- 70 μg/ml	26
5	RSG+MET	Tablet	UV-Visible detector	230 nm	Sodium dihydrogen phosphate buffer (pH 3.5): acetonitrile 60:40, v/v	Phenomenex C18 (4.6 mm x 250 mm, 5 μm)	0.7ml/min	11.95 min, 3.35 min	0.03125 to 0.50 μmole/ml	27
6	RSG	Tablet And Serum	UV detector	248nm	Methanol: Acetonitrile 80:20v/V	Intersil ODS C18 column ( 250 x 4.6mm , 5μm)	1 m1/ min	3.425 min	3-18μg/ml	28
7	RSG+ GLM	Human Plasma	UV detector	228 nm	Mixture of phosphate buffer (50 mM) with octane sulfonic acid (10 mM): Methanol: Acetonitrile (55:10:35, v/v). pH was adjusted to 7.0	LiChrosphere 100 RP C18, (125x 4mm, 5 μm)	1 ml/ min	8.4 min, 6.4 min	40.994–2007.556 ng /ml, 41.066–2094.84 ng/mL	29
8	RSG+GLZ+PIO+GLI+GLM	Human plasma And tablet	UV detector	248 nm	0.05% Triethylamine (pH-3.5, adjusted with OPA): Acetonitrile: Methanol in 55:15:30 v/v	Phenomenex C18 column (150 x 4.6 mm, 5μm)	1 ml/ min	9.26,4.51, 11.3,17.78&14.76 min	0.1-100 μg/ml	30
9	RSG+ GLD	Bulk And tablet	UV Visible detector	225 nm	Potassium dihydrogen phosphate (pH-7): Acetonitrile 60:40v/v	Hypersil C18 (250 mm x 4.6mm, 5μm)	1 ml / min	17.36 min, 7.06 min	5-70 μg/ml	31
10	RSG+ GLD	Tablet	photodiode array detector	235 nm	Method I: Acetonotrile: Water (1.5%HCl) 40:60 v/v   Method II: Acetonitrile: Ammonium acetate buffer (pH-4.5)55:45 v/v	XterraC18(250mm x 4.6mm, 5μm)	1 ml/ min	Method I 1.98min, 3.02min Method II	Method I&II For RSG 5-250 μg/ml, 10-240 μg/ml   Method I&II For GLD 2-300 μg/ml, 2-160 μg/ml	32
11	RSG+MET	Bulk And Tablet	PDA detector	220 nm.	0.1% Orthophosphoric acid: Methanol 40:60 v/v	Phenomenex C8 (150 mm x 4.6 mm, 5μm)	1 ml/ min	2.919 min,  2.176 min	1-30 μg/ml, 500-1500 μg/ml	33
12	RSG+GLD	Tablet	UV detector	254 nm	Acetonitrile: phosphate buffer (pH 4.5): Methanol 50:35:15 v/v)	Phenomenix Gemini C-18 (250 x 4.6 mm, 5 μm)	1 ml/ min	3.74 min, 7.84 min	-	34
13	RSG	Sheep plasma and Amniotic fluid	fluorescence detector	EX247 nm, EM367 nm	Ammonium acetate (10mM, pH 5.2): Acetonitrile 56.5:43.5v/v	Phenomenx C18 column (GEMINI 5 5 μm 110A◦, Australia)	1 ml/ min	9 min	2.5–250 ng/ml	35
14	RSG	Human plasma	fluorescence detector	EX247 nm, EM367 nm	10mM Sodium acetate–Acetonitrile (pH 5; 60:40, v/v)	Alltima phenyl columns (250mm x 4.6 mm, 5 μm)	1 ml/ min	7.9 min	5–1000 ng/ml	36
15	RSG+MET	Bulk	UV detector	226 nm	Acetonitrile:10mM disodium hydrogen Phsosphate buffer: 5mM sodium dodecyl sulphate 34:66(v/v), and pH is adjusted to 7.1 with OPA	Zorbax XDB C18 (4.6 x 150 mm, 5 μm)	1 ml/ min	-	0.2–1.2 μg/ml RSG, 25–150 μg/ml MET	37
16	RSG+GLD	Bulk	UV detector	250nm	Acetonitrile: Water (pH 3 adjusted with OPA)70: 30 v/v	Phenomenex Gemini reverse phase C18 column (150 x 4.6mm, 5μm)	0.6ml/min	2.41min,  5.22min	0.025-2.5μg/ml, 0.08 to 8μg/ml	38
17	RSG+MET	Plasma	UV detector	245nm	A gradient consisting of acetonitrile and 5mM pH 5.5 sodium acetate (adjusted with 1M glacial acetic acid)	Ace 5 phenyl column (250mm x 4.6mm, 5 μm)	1 ml/ min	3.46min, 5.26min	100.0– 2500.0 ng/mL, 250.0–2500.0 ng/mL	39
18	RSG+MET	Bulk and Tablet	UV detector	245nm	Acetonitrile:10 mM pH 5.5 KH2PO4 (adjusted with 10 mM Na2HPO4) (70:30 v/v)	Ace 5 phenyl column (250 x 4.6 mm, 5 μm)	1 ml/ min	4.26min, 3.33 min	0.05-1.2lμg/ml, 5.0–80.0 μg/ml	40
19	RSG+GLI+GLD+GLP+PIO+ REG	Human Plasma	UV detector	260 nm	The mobile phase consisted of 0.01 m formic acid (pH 3.0), Acetonitrile, Milli Q water and Methanol	Intertsil ODS 3V column (4.6 x 250 mm, 5 μm)	1 ml / min	25.4,20.78,17.6,14.8,13.3,11.4 min respectively	0.1 to 100 μg/ml, 0.3–100 μg/ml(GLI)	41
20	RSG	Tablet	UV detector	274 nm	25mM Potassium dihydrogen phosphate buffer and Acetonitrile (55:45, v/v), adjusted the pH with 6.	RP-C18column (125 x 4.0 mm)	0.8 ml/ min	6.109 min	4–16.0 μg/ml	42
21	RSG, DIL, MET and PIO	Human serum	UV–vis detector	230 nm	Acetonitrile: Methanol: Water (30:20:50, v/v, pH 2.59 )	Hiber 250 x 4.6 RP-18 column	1.0 ml/ min	3.1, 5.3, 2.34and 3.8 respectively	0.78- 50.0 μg/ml	43
22	RSG	Human Plasma	Fluorescence Detector	EX247nm, EM367 nm	0.01 M Dibasic potassium hydrogen phosphate (pH 6.5) and Acetonitrile (65:35, v/v)	Nova-pak C18 cartridge	2.0 min/ ml	6.4 min	5-800 ng/ml	44
23	RSG	Bulk and Tablet	Photodiode array detector	245 nm	Sodium phosphate buffer (pH adjusted to 6.2): Acetonitrile (50:50, v/v)	Hichrom RPB, (4.6×250 mm, 5 μm	1.0 ml/ min	7.6 min	0.45-10 μg/ml	45
24	RSG	Human Plasma	Fluorescence Detector	EX247nm, EM367 nm	Acetonitrile and 20mM Ammonium acetate (52:48, pH 7.5)	Capcell Pak MG120 column (250 x 1.5 mm, 5 μm	0.2 ml/ min	4.7 min	10 to 2000 ng/ml	46
25	RSG	Plasma	Fluorescence Detector	EX247nm, EM367 nm	Potassium dihydrogen phosphate buffer (0.01M, pH 6.5): Acetonitrile: Methanol (40:50:10, v/v/v)	Hichrom KR 100, 250 x 4.6 mm, 5 μm	1.0 ml/ min	8.0 min	5–1000 ng/ml	47
26	RSG,MET and GLM	Tablet	PDA detector	238 nm	Methnol: Acetonitrile: Phosphate Buffer, pH 5.39 (20: 40: 40 % v/v/v)	RP-C18 (250 x 4.6 mm ,2.27µm)	1.0 ml/ min	8.18, 3.69 and 12.5 min respectively	4-24 μg/ml	48

High-Performance Thin Layer Chromatography (HPTLC)

Dhole Seema M. et al⁴⁹reported the HPTLC method for simultaneous determination of RSG and GLM in the tablet dosage form. The elution was done by using on aluminum plates pre-coated with silica gel 60 F254 with the solvent system composed of methanol: toluene: ethyl acetate in a ratio of (1:8:1, v/v/v)w. The assessmentof RSG and GLM was out at 228 nm. The analyte was separated with Rf values 0.39 ± 0.03 forRSG and 0.20 ± 0.04 GLM. The correlation coefficient for RSG found 0.9989 and for GLM0.9989. The % recovery was found to be 100%. The method was validated and found suitable for routine analysis of RSG and MET.

 

Susheel J V et al⁵⁰ established the HPLC method for simultaneous estimation of RSG and MET in combined tablet dosage forms. the HPTLC method developed by taking precoated silica gel 60F254 and elution was carriedby methanol-tetrahydrofuran-ammonia, 8:3:1.5 (v/v/v), as the mobile phase the estimation carried out at 262 nm by using UV detector. The linearity range found in between 0.12 to 0.48 and 15 to 60 μg/band for RSG and MET respectively. The % recovery found in between 98 to 103% for RSG and MET. The method was validated for like accuracy, precision, linearity, and specificity.

 

Anna Gumieniczek et al⁵¹ developed the stability indicating HPTLC method for RSG in the tablet dosage form. The chromatographic elution performed on silica gel 60F254 as the stationary phase and chloroform-ethyl acetate–25% ammonium hydroxide (5:5: 0.1, v/v/v) as mobile phase. the quantification of analyte was carried out at 240 and 254 nm by the densiometric method. the analyte was extracted from a tablet with the help of ethanol. the linearity range was plotted in between 0.2-1.0 μg/10μl and the correlation coefficient was found 0.9993 and 0.9994 at 240 nm and 254 nm respectively. the average recoveries from tablet found 101.95% and 103.2% at 240 and 254 nm respectively.

 

Hoda Mahgoub et al⁵² reported the method for simultaneous determination of RSG and MET in synthetic mixture and in the pharmaceutical dosage form. The separation was achieved on Merck HPTLC aluminium sheets of silica gel 60F254 using methanol: water: NH₄Cl 1% w/v (5:4:1 v/v/v) as the mobile phase the calibration range was found in between 0.4–2.0μg /band for RSG and 20.0–100.0 μg /band MET the method was validated according to ICH guidelines.

 

Walode S. G. et al⁵³ reported the simple rapid and precise HPTLC method for RSG and caffeine was used as the internal standard in the tablet dosage form. the chromatographic separation was done on silica gel 60 GF254 plates using the phase methanol: toluene: chloroform: triethylamine (1:8:0.5:0.5 v/v/v/v) as a solvent system and detection was carried out at 264nm having Rf value 0.31 for RSG and 0.25for caffeine. The linearity curve was found 1.0-7.0 μg/μl the percentage content from two different brands was found in between 99.83-100.21.

 

Jiladia Meeta A et al⁵⁴ developed the method for estimation of RSG in tablet dosage form. The separation was carry out on silica Gel 60 F₂₅₄TLC plate using Toluene: acetone: ammonia (4.5:5.5:0.1 v/v) as mobile phase. The detection was carried out at 318nm using Camag TLC Scanner 3 having the Rf value 0.55. The Method was validated according to ICH guidelines. The method can be used for routine qualitative analysis the. The summary of all the above methods was given in Table 3.

 

 

 

Table 3 HPTLC methods of Rosiglitazone

Sr. No	Name of Drug	Sample matrix	Mobile Phase	Detection	Linearity	Rf	Reference
1	RSG+GLM	Tablet	Methanol: Toluene: Ethyl acetate in a ratio of (1:8:1, v/v/v)	228nm	1 to 15 μl	0.39 and 0.20	49
2	RSG+MET	Tablet	methanol-tetrahydrofuran-ammonia, 8:3:1.5 (v/v/v)	262 nm	0.12 to 0.48 and15 to 60 μg/band	0.34 and 0.54	50
3	RSG	Tablet	Chloroform:Ethyl acetate:25% Ammonium hydroxide (5:5: 0.1, v/v/v)	240 and 254 nm	0.2-1.0 μg/10μl	0.52	51
4	RSG+MET	Tablet and Synthetic mixture	Methanol: Water: NH4Cl 1% w/v (5:4:1 v/v/v)	230 nm	0.4–2.0μg /band and20.0–100.0 μg /band	0.7 and 0.4	52
5	RSG	Tablet	Methanol: Toluene: Chloroform: Triethylamine (1:8:0.5:0.5 v/v/v/v)	264 nm	1.0-7.0 μg/μl	0.31	53
6	RSG	Tablet	Toluene: acetone: ammonia (4.5:5.5:0.1 v/v/v)	318 nm	200–2000 ng/spot	0.55	54

 

 

 

Capillary Electrophoresis:

Nuran Ozaltın et al⁵⁵ reported simultaneous analysis of RSG and MET in pharmaceutical dosage forms. The separation was achieved with a fused-silica capillary column (80.5 cm×75μm i.d, effective length 72.0 cm) having running buffer 25mMacetate buffer at pH 4.0 the components was separated less than 9 min at 25°C. The sample was injected by hydrodynamically for 3s at 50mbar and the applied voltage was+25.0 kV. The verapamil was used as the internal standard and detection was carried out at 203 nm. The method was validated in terms of specificity, linearity, limit of detection and quantitation, accuracy, precision, and robustness.

 

CE-ESI-MS:

Joanna Znaleziona et al⁵⁶ established new method quantification of MET and RSG using the two techniques capillary electrophoresis with electrospray mass spectrometry. The resolution was achieved at 11 in between 11 min with 50mM formic acid at 120 kV. Positive electrospray ionization and selected ion monitoring [M+H]⁺ of metformin (m/z5130) and rosiglitazone (m/z5358) were performed. The parameter which influences the electrospray ionization was measured. The sheath solution composition taken as water/methanol/formic acid (50:49.5:0.5, v/v/v) with flow rate 2.0 microl/min. The proposed method was used for the estimation of MET and RSG in human plasma. The LOD of method was found 4.42 and 2.14 ng/ml for RSG and MET respectively.

 

LC-ESI-MS-MS:

Grace O’Maille et al⁵⁷ developed the fast, sensitive method for simultaneous determination of RSG and N-desmethyl RSG in human plasma. For this method, internal standard rosiglitazone-d4 and N-desmethyl rosiglitazone-d4 for RSG and N-desmethyl RSG was used respectively. The analyte from human plasma was separated from through liquid/liquid extraction and elution was carried out over 3 min. The precursor ion was determined by ESI–MS–MS with multiple reaction Monitoring use of a triple quadrupole mass spectrometer. The LOQ for RSG and N-desmethylwas found 1.00 ng/ml and calibaration range was found over range of 1.00–500 ng/ml.

 

Hong-Hao Zhou et al⁵⁸ reported the sensitive and selective LC-ESI-MS-MS method for estimation of RSG in human plasma. The HPLC separation was carried out by using a proC18 column using a mixture of ammonium acetate buffer (0.02 M, pH 6.5) and acetonitrile (in the ratio of 47:53, v/v) as mobile phase. the calibration range found between 1–1000 ng/ml. The lower limit of quantitation was found at 1.0 ng/ml having precision 5.7% the method was developed for the measure the pharmacokinetic profile of RSG in healthy volunteers. A possible chromatography peak (m/z 121, its parent ion m/z 344) of N-demethyl rosiglitazone was observed at 3.49 min during determining rosiglitazone this method also found potential to measure the simultaneous estimation of RSG and its metabolite in plasma.

 

LC-MSMS:

Fakhrul Ahsan et al⁵⁹ established validated LC–MS/MS method for estimation sildenafil and RSG.The method was validated for pharmacokinetic study of sildenafil and RSG zone after intravenous administration of sildenafil alone or a combination of sildenafil plus rosiglitazone to adult male Sprague-Dawley .the extraction of analyte was done by using methanol the analyte was eluted with gradient elution with C18 column having mobile phase and formic acid in methanol or in water as the mobile phase with a flow rate of 0.25 mL/min the calibration range was found in between 5 and 1000 ng/ml.

 

Sara Allstadt Frazier et al⁶⁰ reported extraction less method for quantification of RSG in Canine Plasma and test. The pharmacokinetic c study of the drug was observed after the administration of the drug in Dog having cancer. The HPLC-MS/MS method was developed for the determination of RSG in canine Plasma. The LC separation was carried out C18 Column (100 X 2.1, 2um) and temperature of column maintained at 27 °C with mobile phase Acetonitrile and 0.2% formic acid. In mass spectroscopy Nitrogen Gas were used as sheath gas and 45lb/square inch pressure used and auxillary gas 10 arbitrary unit maintained. The spray voltage set at about 4000V and positive ionization mode was used and 355°C temperature was set for capillary. Argon gas was used as the collision gas with pressure 2.0 mmHg. The RSG the protonated ion [M+H]+ 358.1 and Internal standard PIO the protonated ion [M+H]+ 357.1 was isolated and fragmented.

 

Zhongping John Lin et al⁶¹ developed the method to observe the RSG and GLP Drug-Drug protein binding interaction and method was validated for simultaneous estimation of free drug in plasma and to extract free RSG and GLP equilibrium dialysis was used. The free unbound drug was quantified with using high performance liquid chromatography electrospray tandem mass spectrometer. In HPLC system compound was eluted with isocratic separation usingZorbax SB-Phenyl column with acetonitrile: water (50:50) with 10mM ammonium acetate and 0.02% TFA as mobile phase at flow rate of 0.3 ml/0min.The eluted sample was ionised with atmospheric pressure electrospray ionization method with positive ion mode. The ion transitions monitored were m/z 446 → 321 for glipizide, m/z 358 →135 for rosiglitazone, and m/z 271→155 for tolbutamide which used as internal standard. The Rention time for GLP, RSG andtolbutamide found 2.3, 3.4 and 2.3 min respectively and according to developed method GLP and RSG found 99% bound to plasma protein and free fraction of GLP and RSG was found 0.678and 0.389 Respectively.

 

Voltammetric methods for analysis

Sibel A. Ozkan et al⁶² studied the anodic voltammetric behaviour and resolution of RSG in pharmaceutical dosage forms and biological fluids on solid electrode. Different parameters were tested to optimize the conditions for the determination of the oxidation mechanism of rosiglitazone. The requirement of current intensities and potentials on pH, concentration, scan rate, nature of the buffer was also investigated. According to the linear relationship between the peak current and the concentration, differential pulse and square wave Voltammetric methods for RSG assay in pharmaceutical dosage forms and biological fluids were developed. A linear response was found within the series of 1x10^-6M – 6 x10^-5M in 0.1 M H₂SO₄ and acetate buffer at pH 5.70 for both Voltammetric methods in human serum samples. The practical analytical value of the method was established by quantitative determination of RSG in pharmaceutical formulation and human serum, without the need for separation or complex sample preparation, since there was no interference from the additives and endogenous substances.

 

Ali F. Al-Ghamdi et al⁶³ investigated the square-wave adsorptive stripping voltammetry technique for estimation of RSG by using the hanging mercury dropping electrode surface with Britton Robinson buffer, pH 5. The response was characterised in termsofpH, supporting electrolyte, accumulation potential, pre-concentration time, scan rate, frequency, pulse amplitude, surface area of the working electrode and the convection rate. The Voltammetric current is proportionate to the concentration of RSG in between 5 x 10^-8 –8 x 10^-7 mol^-1havinga detection limit of 2 x 10^-11mol l^-1 with 120s accumulation time. the developed method show good reproducibility, the % RSD for concentration 5 x 10^-7 mol^-1 was found 0.33% and accuracy was found 101 %. thus developed method can apply for the determination of RSG in the human urine and plasma samples.

 

Dina El-Sherbiny et al⁶⁴ studied the Voltammetric behaviour RSG by using the direct current, differential pulse, and alternating current polarography. The drug shows the cathodic waves in between pH range 2-11.2 in Britton-Robinson buffer pH 4. The RSG shows diffusion current vsconcentration linear in the range of 4–24 µg/ mL^-1 and 0.1–16µg /mL^-1 having a limit of detection 0.15µg/mL^-1 and 0.07 µg/mL^-1 using the direct current, differential pulse modes respectively. The developed method was applied for the estimation of RSG in pure and pharmaceutical formulations. The % recovery for the tablet was found 100.09 and 100.85 for direct current, differential pulse respectively.

 

CONCLUSION:

The present review revealed that there is a broad range of analytical methods accessible to determine the RSG in Biological samples and Pharmaceutical preparations which includes UV/Vis spectrophotometry, HPLC, HPTLC, capillary electrophoresis, electrochemical method and Hyphenated technique.

 

ABBREVIATIONS

Sr. No	Name	Abbreviation
1	Rosiglitazone	RSG
2	Gemfibrozil	GEM
3	Glimepiride	GLM
4	Metformin	MET
5	Glipizide	GLZ
6	Pioglitazone	PIO
7	Glibenclamide	GLI
8	Gliclazide	GLD
9	Sitagliptin	SIT
10	Glipizide	GLP
11	Repaglinide	REG
12	Diltiazem	DIL
12	High Performance Liquid chromatography	HPLC
13	Millimoles Per Litre	mmol/l
14	Milliliter	ml
15	Nanogram	ng
16	Millimetre	mm
17	Reverse Phase- High Performance Liquid chromatography	RP-HPLC
18	Volume /Volume	V/V
19	Micrometer	μm
20	Microgram	μg
21	Excitation/Emission	EX/EM
22	Kilovolt	kV
23	High Performance Thin Layer Liquid Chromatography	HTPLC
24	Liquid Chromatography	LC
25	Electrospray Ionization	ESI
26	Mass spectroscopy	MS
27	Verses	vs
28	Percent	%
29	Relative standard Deviation	RSD

 

REFERENCES:

1.      Whiting DR, Guariguata L, Weil C, Shaw J. IDF Diabetes Atlas: Global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Research and Clinical Practice. 2011; 94(3):311–321.

2.      Preethikaa S, Brundha MP. Awareness of diabetes mellitus among general population. Research Journal of Pharmacy and Technology. 2018;11(5):1825-1829.

3.      Manikandan R, Sarumathy S. Clinical study on assessment of lipid Profile and renal function in type 2 Diabetic patients-A Retrospective Study. Research Journal of Pharmacy and Technology. 2018;11(4):1624-1626.

4.      Kumari MS, Babu MK, Sulthana MR, Srinivas M, Prasanthi C. Diabetes Mellitus: Present status and Drug therapy Updates. Research Journal of Pharmacy and Technology. 2014;7(1):9.

5.      AhmedAM.History of diabetes mellitus. Saudi Medical Journal,2002;23(4):373-8. Available from: URL:https://www. ncbi.nlm.nih.gov/pubmed/11953758

6.      Olokoba AB, Obateru OA. Olokoba LB. Type 2 diabetes mellitus: A review of current trends. Oman medical journal,2012;27(4);269.

7.      Bhanushali SM, Modh KM, Anand IS, Patel CN, Dave JB. Novel Approaches for Diabetes Mellitus: A Review. Research Journal of Pharmacology and Pharmacodynamics. 2010;2(2):141-147.

8.      Dewangan V, Pandey H. Pathophysiology and Management of Diabetes: A Review. Research Journal of Pharmacology and Pharmacodynamics. 2017;9(4):219-222.

9.      Panari H, Vegunarani M. Study on Complications of Diabetes Mellitus among the Diabetic Patients. Asian Journal of Nursing Education and Research. 2016 Apr 1;6(2):171.

10.   Somwanshi SB, Bairagi PD, Kotade KB. Study of Gestational Diabetes Mellitus: A Brief Review. Asian Journal of Pharmaceutical Research. 2017;7(2):118-123.

11.   Advances & Emerging Opportunities in Diabetes Research: A Strategic Planning Report of the Diabetes Mellitus Interagency Coordinating Committee. National Institute of Diabetes and Digestive and Kidney Diseases. 2018.Available from : URL:https://www.niddk.nih.gov//media/Files/Strategic-Plans/Advances-in Diabetes/DSP2011_01_Summary Future Directions_508.pdf

12.   Maheshwari P, Shanmugarajan TS. Gestational Diabetes mellitus effects on Macrosomia and risk of Developing Type 2 Diabetes in Tertiary care hospital. Research Journal of Pharmacy and Technology. 2017 Jun 1;10(6):1589.

13.   Pubchem. (n.d.). Rosiglitazone. Available from:URL: https://pubchem.ncbi.nlm.nih.gov/compound/rosiglitazone#section=Names-and-Identifiers

14.   CraigC, StitzelR, Modern pharmacology with clinical applications. Lippincott Williams & Wilkins, Philadelphia. 2004

15.   Gupta A, Chaturvedi P, Shrivastava SK, Dubey PK. Glitazones for the Treatment of Diabetes Type-2. Asian Journal of Research in Chemistry. 2012 Feb 1;5(2):164.

16.   MartindaleW,SweetmanS.Martindale. 31st ed. Pharmaceutical Press,London .2007

17.   Indian Pharmacopoeia 2010, Govt. of India, Ministry of Health and Family Welfare. Delhi: Indian Pharmacopoeial commission, Ghaziabad. 2010

18.   Khedekar PB, Dhole SM, Bhusari KP. Application of vierodt’s and absorption correction spectrophotometric methods for estimation of rosiglitazone maleate and glimepiride in tablets. Digest Journal of Nanomaterial’s and Biostructures.2010;5(1):77–84.

19.   Adhikari L, Mishra US, Murthy PN. Spectrophotometric estimation and statistical correlation for Rosiglitazone in rat and human plasma. Asian Journal of Pharmaceutical and Clinical Research.2013;6(3):138–41.

20.   Goyal A,Singhvi I. Simultaneous spectrophotometric estimation of rosiglitazone maleate and glimepiride in tablet dosage forms. Indian Journal of pharmaceutical sciences. 2007;69(6):780.

21.   Jain R, Kashaw SK, Mishra P. Spectrophotometric determination of rosiglitazone maleate in tablets. Asian Journal of Chemistry. 2008;20(3):1781–1785.

22.   Goyal VK, Kulkarni AS, Dhabale PN. Simultaneous spectrophotometric estimation of rosiglitazone maleate and gliclazide in pharmaceutical tablet dosage form. Asian J Res Chem. 2009 Jun 28;2:353.

23.    Kang X, Wang F, Xie Z, Li H. A high performance liquid chromatography method for simultaneous determination of rosiglitazone and gemfibrozil in human plasma.Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences. 2009;877(7):645–648.

24.   Madhusudhan P, Reddy MR, Devanna N. A RP-HPLC method development and validation for simultaneous estimation of metformin HCl and rosiglitazone in bulk and tablet dosage form. Der Pharmacia Lettre. 2015;7(3):180–187.

25.   El-Enany NM, Abdelal AA, Belal FF, Itoh YI, Nakamura MN. Development and validation of a Reverse phase- HPLC method for simultaneous determination of rosiglitazone and glimepiride in combined dosage forms and human plasma. Chemistry Central Journal . 2012;6(1):9.

26.   Mittan DS, Dwivedi SC, Kushnoor A. Development and Validation of a RP-HPLC Method for Simultaneous Estimation of Rosiglitazone and Metformin in Bulk and Tablet Dosage Form. Eurasian Journal of Analytical Chemistry. 2011;6(3):189-96.

27.   Akteruzzaman M, Rahman A, Sultan MZ, Islam F, Salam MA, Rashid MA. Development and validation of a simple RP-HPLC method for simultaneous estimation of metformin hydrochloride and rosiglitazone in pharmaceutical dosage forms.Dhaka University Journal of Pharmaceutical Sciences. 2012;11(2):157–163.

28.   RayanamIV,RaoAL,Ramana MV. Development and validation of LC method for the estimation of rosiglitazone in pharmaceutical dosage form and serum. Pharmanest–An International Journal of Advances In Pharmaceutical Sciences. 2011;2(1).

29.   Jingar JN, Rajput SJ, Dasandi B, Rathnam S. Development and validation of LC-UV for simultaneous estimation of rosiglitazone and glimepride in human plasma. Chromatographia. 2008 ;67(11-12):951-5.

30.   Lakshmi KS, Rajesh TT. Development and validation of RP-HPLC method for simultaneous determination of glipizide, rosiglitazone, pioglitazone, glibenclamide and glimepiride in pharmaceutical dosage forms andhuman plasma.Journal of the Iranian Chemical Society. 2011;8(1):31–37.

31.   Baghel US, Shrivastava B, Kumar D, Tiwari AP. Gradient HPLC method development and validation for Simultaneous estimation of Rosiglitazone and Gliclazide. Asian Pacific Journal of Tropical Disease.2012; 2(2):S756–760.

32.   Adhikari L, Mishra US, Murthy PN. Method development and statistical comparison for Rosiglitazone and Gliclazide in combined dosage form. Der PharmaChemica. 2014;6(1):24–30.

33.   Jahnavi DS, Venkata D, Rao N, Reddy YR. RP-HPLC method for the quantification of Metformin and Rosiglitazone in bulk and combined tablet dosage form : method development and validation. Journal of Innovations in Pharmaceutical and Biological Sciences ( JIPBS ).2016; 3(4): 55-60.

34.   Rathinavel G, Uma Nath U, Valarmathy J, Samueljoshua L, SelvinThanuja C, Ganesh M, et al. RP-HPLC method for the simultaneous estimation of rosiglitazone and gliclazide in tablets. E-Journal of Chemistry.2009;6(4):1188–1192.

35.   Bazargan M, Davey AK, Muhlhausler BS, Morrison JL, McMillen IC, Foster DJR. Simple HPLC method for determination of rosiglitazone in sheep plasma and amniotic fluid and its application in a pregnant sheep model. Journal of Pharmaceutical and Biomedical Analysis.2011; 55(2):360–365.

36.   Hruska MW, Frye RF. Simplified method for determination of rosiglitazone in human plasma. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences. 2004;803(2):317–320.

37.   Kolte BL, Raut BB, Deo AA, Bagool MA, ShindeDB.Simultaneous determination of metformin in combination with rosiglitazone by reversed-phase liquid chromatography. Journal of chromatographic science. 2004;42(2):70-73.

38.   Lakshmi KS, Rajesh T. Simultaneous determination of rosiglitazone and gliclazide in pharmaceutical dosage forms by high performance liquid chromatography. Journal of the Chilean Chemical Society.2010;55(2):250–252.

39.   Yardimci C, Özaltin N, Gürlek A. Simultaneous determination of rosiglitazone and metformin in plasma by gradient liquid chromatography with UV detection. Talanta. 2007;72(4):1416–1422.

40.   Yardımcı C, Özaltın N. Simultaneous Determination of Rosiglitazone and Metformin in Pharmaceutical Preparations by LC. Chromatographia . 2007;66(7–8):589–593.

41.   Venkatesh P, Harisudhan T, Choudhury H, Mullangi R, Srinivas NR. Simultaneous estimation of six anti-diabetic drugs - Glibenclamide, gliclazide, glipizide, pioglitazone, repaglinide and rosiglitazone: Development of a novel HPLC method for use in the analysis of pharmaceutical formulations and its application to human. Biomedical Chromatography. 2006; 20(10):1043–1048.

42.   Gomes P, Sippel J, Jablonski A, Steppe M. Determination of rosiglitazone in coated tablets by MEKC and HPLC methods. Journal of Pharmaceutical and Biomedical Analysis. 2004; 36(4): 909–913.

43.   Sultana N, Arayne MS, Shafi N, Siddiqui FA, Hussain A. Development and validation of new assay method for the simultaneous analysis of diltiazem, metformin, pioglitazone and rosiglitazone by RP-HPLC and its applications in pharmaceuticals and human serum. Journal of Chromatographic Science. 2011;49(10):774–779.

44.   Yusuf A, Alvi SN, Hammami MM. Development and validation of RP-HPLC method for the determination of rosiglitazone in human Plasma. 2015; 4(03): 231–242.

45.   Radhakrishna T, Satyanarayana J, Satyanarayana A. LC determination of rosiglitazone in bulk and pharmaceutical formulation. Journal of Pharmaceutical and Biomedical Analysis. 2002; 29(5):873-880.

46.   Kim KA, Park JY. Simple and extractionless high-performance liquid chromatographic determination of rosiglitazone in human plasma and application to pharmacokinetics in humans. Biomedical Chromatography.2004;18(8):613–615.

47.   Mamidi RN, Benjamin B, Ramesh M, Srinivas NR. Simple method for the determination of rosiglitazone in human plasma using a commercially available internal standard. Biomedical Chromatography.2003;17(6):417-20.

48.   Ramolia C, Dedania Z, Dedania R, Sheth NR, Patel B, Bhatt KK. Simultaneous estimation of metformin hydrochloride, rosiglitazone maleate and glimepiride in pharmaceutical dosage forms by RP-HPLC method. Asian Journal of Research in Chemistry. 2010;3(1):83-6.

49.   Dhole SM, Khedekar PB, Amnerkar ND. Development and validation of HPTLC densitometry method for simultaneous estimation of rosiglitazone and glimepiride in fixed tablet dosage form. Journal of the Chilean Chemical Society.2013;58(2):1663-1666.

50.   Susheel JV, PaulD, Ravi TK. Development and Validation of High-Performance Thin- Layer Chromatography Method for the Simultaneous Densitometric Determination of Metformin and Rosiglitazone in Tablets. Austin Journal of Analytical and Pharmaceutical Chemistry. 2016; 3(3):1–4.

51.   Gumieniczek A, Berecka A, Hopkala H, Mroczek T. Rapid HPTLC determination of rosiglitazone in pharmaceutical formulations. Journal of liquid chromatography & related technologies. 2003; 26(19): 3307-3314.

52.   Mahgoub H, Youssef RM, Korany MA, Khamis EF, Kamal MF. Development and validation of spectrophotometric and HPTLC methods for simultaneous determination of rosiglitazone maleate and metformin hydrochloride in the presence of interfering matrix excipients. Drug Development and Industrial Pharmacy. 2014; 40(9): 1190-1198.

53.   Walode SG, Chaudhari HK, Saraswat MS, Kasture AV, Wadodkar SG. Validated high performance thin layer chromatographic determination and content uniformity test for rosiglitazone in tablets. Indian Journal of Pharmaceutical Sciences. 2010; 72(2): 249.

54.   Jiladia MA, Pandya SS, Jiladia AG, Viidyasagar G. Estimation of Rosiglitazone in Bulk and Tablet Dosage Forms by HPTLC Method. Asian Journal of Research in Chemistry. 2010; 3(1): 26-8.

55.   Yardımcı C, Özaltın N. Method development and validation for the simultaneous determination of rosiglitazone and metformin in pharmaceutical preparations by capillary zone electrophoresis. Analytica Chimica Acta. 2005;549(1-2):88-95.

56.   Znaleziona J, Maier V, Ranc V, Ševčík J. Determination of rosiglitazone and metformin in human serum by CE‐ESI‐MS. Journal of Separation Science. 2011;34(10):1167-73.

57.   O’maille G, Pai SM, Tao X, Douglas Jr GT, Jenkins RG. An improved LC–ESI–MS–MS method for simultaneous quantitation of rosiglitazone and N-desmethyl rosiglitazone in human plasma. Journal of Pharmaceutical and Biomedical Analysis. 2008; 48(3): 934-939.

58.   He J, Hu YF, Duan LF, Tan ZR, Wang LS, Wang D, Zhang W, Li Z, Liu J, Tu JH, Yao YM. Sensitive and selective liquid chromatography–mass spectrometry method for the quantification of rosiglitazone in human plasma. Journal of Pharmaceutical and Biomedical Analysis.2007;43(2):580-585.

59.   Rashid J, Ahsan F.A highly sensitive LC–MS/MS method for concurrent determination of sildenafil and rosiglitazone in rat plasma. Journal of Pharmaceutical and Biomedical Analysis. 2016; 129: 21-27.

60.   Frazier SA, McKemie DS, Guerrero TA, Skorupski KA, Rodriguez Jr CO. Evaluation of an extractionless high-performance liquid chromatography-tandem mass spectrometry method for detection and quantitation of rosiglitazone in canine plasma. American Journal of Veterinary Research. 2011; 72(2): 263-270.

61.   Lin ZJ, Desai-Krieger D, Shum L. Simultaneous determination of glipizide and rosiglitazone unbound drug concentrations in plasma by equilibrium dialysis and liquid chromatography–tandem mass spectrometry. Journal of Chromatography B. 2004 Mar 5; 801(2): 265-272.

62.   Dogan-Topal B, Tuncel S, A Ozkan S. Anodic Voltammetric behaviour and determination of rosiglitazone in pharmaceutical dosage forms and biological fluids on solid electrode. Combinatorial Chemistry & High Throughput Screening. 2010; 13(8): 694-702.

63.   Al-Ghamdi AF, Hefnawy MM. Electrochemical determination of rosiglitazone by square-wave adsorptive stripping voltammetry method. Arabian Journal of Chemistry.s2012 Jul 1;5(3):383-389.

64.   El‐Sherbiny D, El‐Enany N, Belal F. Voltammetric determination of rosiglitazone in pharmaceutical preparations and human plasma. Analytical Letters. 200; 41(5): 806-821.

 

 

 

 

Received on 15.03.2019                 Accepted on 10.04.2019

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Asian J. Pharm. Ana. 2019; 9(3):167-176.