Author(s): Pooja L. Kumbhar, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde

Email(s): kumbhar18pooja@gmail.com

DOI: 10.52711/2231-5675.2024.00013   

Address: Pooja L. Kumbhar*, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde
Department of Pharmaceutical Chemistry, Government College of Pharmacy, Karad 415124, Maharashtra, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2024


ABSTRACT:
For the simultaneous estimation of Itraconazole (ITZ) and Terbinafine hydrochloride (TBF HCl) in tablet dosage form, a simple, novel, cost effective and rapid RP-HPLC method was developed. Method development becomes quick, accurate, sensitive, and robust by using quality by design (QbD). RP-HPLC was performed using a C18 (agilent, 4.6 x 250mm, 5µm particle size) column. Methanol and 0.05% OPA (pH 3.5) was used as mobile phase in 84:16 ratio. The analysis was conducted in gradient mode with a flow rate of 0.95mL/min. Detection wavelength was set at 270nm. Retention time for TBF and ITZ was at 2.93 and 6.96min, respectively. The accuracy, precision, repeatability, linearity, LOD, LOQ and robustness parameters have been validated as per the ICH Q2 (R1) guideline: Validation of analytical procedures–text and methodology. Values for LOD and LOQ were found to be 0.131 and 0.398µg/mL and 0.350 and 1.061µg/mL respectively for ITZ and TBF HCl. Thus, the technique can be employed for regular QC analysis of bulk ITZ and TBF HCl and their pharmaceutical formulations. Degradative stress conditions like acid, base, neutral, oxidation applied and degradations were studied.


Cite this article:
Pooja L. Kumbhar, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde. QbD Approach to Method Development, Validation and Degradation Profiling of Antifungal Drugs by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2024; 14(2):69-5. doi: 10.52711/2231-5675.2024.00013

Cite(Electronic):
Pooja L. Kumbhar, Anita S. Kulkarni, Rita D. Chakole, Manoj S. Charde. QbD Approach to Method Development, Validation and Degradation Profiling of Antifungal Drugs by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2024; 14(2):69-5. doi: 10.52711/2231-5675.2024.00013   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-2-4


REFERENCES:
1.    Akash MS, Rehman K, Akash MS, Rehman K. Ultraviolet-visible (UV-VIS) spectroscopy. Essentials of Pharmaceutical Analysis. 2020; 29-56. doi.org/10.1007/978-981-15-1547-7_3
2.    Vidushi Y, Meenakshi B, Bharkatiya MB. A review on HPLC method development and validation. Res J Life Sci, Bioinform, Pharm Chem Sci. 2017; 2(6): 178. doi.org/10.26479/2017.0206.12
3.    Watson DG. Pharmaceutical analysis E-book: a textbook for pharmacy students and pharmaceutical chemists. Elsevier Health Sciences; 2020 Jun 10.
4.    Bhatt DA, Rane SI. QbD approach to analytical RPHPLC method development and its validation. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(1): 179-87.
5.    Costa GM, Gazola AC, Madóglio FA, Zucolotto SM, Reginatto FH, Castellanos L, Ramos FA, Duque C, Schenkel EP. Vitexin derivatives as chemical markers in the differentiation of the closely related species Passiflora alata Curtis and Passiflora quadrangularis Linn. Journal of Liquid Chromatography & Related Technologies. 2013 Apr 1; 36(12): 1697-707. doi.org/10.1080/10826076.2012.695316
6.    Kathirvel S, Gayatri Ramya, Rajesh Akki, Prem Kumar. Newer RP-HPLC Method Development and Validation for the Simultaneous Estimation of Terbinafine and Itraconazole in Combined Dosage Form. IJPPR. 2019; 17(1): 233-244.
7.    Rode DM, Rao DN. Stability-indicating method development and validation of itraconazole and terbinafine HCl in bulk and pharmacutical tablet dosage form. Asian J. Pharm. Clin. Res. 2019; 12: 51-5. doi.org/10.22159/ajpcr.2019.v12i9.33922
8.    Vankayalapati Manjusha, P. Sreenivasa Prasanna, K. Thejomoorthy. Stability indicating method development and validation for the estimation of terbinafine and itraconazole in API and tablet dosage form by RP-HPLC. WJPMR. 2021; 7(6): 322-332.
9.    Nistor I, Lebrun P, Ceccato A, Lecomte F, Slama I, Oprean R, Badarau E, Dufour F, Dossou KS, Fillet M, Liégeois JF. Implementation of a design space approach for enantiomeric separations in polar organic solvent chromatography. Journal of Pharmaceutical and Biomedical Analysis. 2013 Feb 23; 74: 273-83. doi.org/10.1016/j.jpba.2012.10.015
10.    Patil AS, Pethe AM. Quality by Design (QbD): A new concept for development of quality pharmaceuticals. International journal of pharmaceutical quality assurance. 2013 Apr;4(2):13-9.
11.    Thakur D, Kaur A, Sharma S. Application of QbD based approach in method development of RP-HPLC for simultaneous estimation of antidiabetic drugs in pharmaceutical dosage form. Journal of Pharmaceutical Investigation. 2017 May; 47(3): 229-39. doi.org/10.1007/s40005-016-0256-x
12.    Jatte KP, Chakole RD, Charde MS. Degradation profiling of lisinopril and hydrochlorothiazide by RP-HPLC method with QBD approach. Asian Journal of Pharmaceutical Analysis. 2021; 11(4): 270-4. doi.org/10.52711/2231-5675.2021.00046
13.    Ashok PK, Dinkar FS. Determination and Development of UV-Spectrophotometric method for the Amodiquine Hydrochloride by using quality by design (QBD) approach. Asian Journal of Pharmaceutical Analysis. 2019; 9(3): 113-7. doi.org/10.5958/2231-5675.2019.00021.8
14.    Leardi R. Experimental design in chemistry: A tutorial. Analytica Chimica Acta. 2009 Oct 12; 652(1-2): 161-72. doi.org/10.1016/j.aca.2009.06.015
15.    Hadjmohammadi MR, Ebrahimi P. Optimization of the separation of anticonvulsant agents in mixed micellar liquid chromatography by experimental design and regression models. Analytica Chimica Acta. 2004 Jul 19; 516(1-2): 141-8. doi.org/10.1016/j.aca.2004.04.019
16.    Vemić A, Stojanović BJ, Stamenković I, Malenović A. Chaotropic agents in liquid chromatographic method development for the simultaneous analysis of levodopa, carbidopa, entacapone and their impurities. Journal of Pharmaceutical and Biomedical Analysis. 2013 Apr 15; 77: 9-15. doi.org/10.1016/j.jpba.2013.01.007
17.    Stojanović BJ. Factorial-based designs in liquid chromatography. Chromatographia. 2013; 5(76): 227-40. doi.org/10.1007/s10337-012-2350-1
18.    Ganorkar SB, Shirkhedkar AA. Design of experiments in liquid chromatography (HPLC) analysis of pharmaceuticals: Analytics, applications, implications and future prospects. Reviews in Analytical Chemistry. 2017 Sep 1; 36(3). doi.org/10.1515/revac-2016-0025
19.    Vogt FG, Kord AS. Development of quality-by-design analytical methods. Journal of Pharmaceutical Sciences. 2011 Mar 1; 100(3): 797-812. doi.org/10.1002/jps.22325
20.    Sahu PK, Ramisetti NR, Cecchi T, Swain S, Patro CS, Panda J. An overview of experimental designs in HPLC method development and validation. Journal of Pharmaceutical and Biomedical Analysis. 2018 Jan 5; 147: 590-611. doi.org/10.1016/j.jpba.2017.05.006
21.    FDA Guidance Document Analytical Procedures and Methods Validation for Drugs and Biologics JULY 2015
22.    Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step-by-step analytical method validation. IOSR J Pharm. 2015 Oct;5(10):7-19.
23.    Sinha VR, Kumria R, Bhinge JR. Stress degradation studies on duloxetine hydrochloride and development of an RP-HPLC method for its determination in capsule formulation. Journal of Chromatographic Science. 2009 Aug 1; 47(7): 589-93. doi.org/10.1093/chromsci/47.7.589
24.    Naidu KR, Kale UN, Shingare MS. Stability indicating RP-HPLC method for simultaneous determination of amlodipine and benazepril hydrochloride from their combination drug product. Journal of Pharmaceutical and Biomedical Analysis. 2005 Sep 1; 39(1-2): 147-55. doi.org/10.1016/j.jpba.2005.04.001
25.    Leyden J. Pharmacokinetics and pharmacology of terbinafine and itraconazole. Journal of the American Academy of Dermatology. 1998 May 1; 38(5): 42-7. doi.org/10.1016/S0190-9622(98)70483-9
26.    Patel RA, Patel MP, Raj HA, Shah N. Forced Degradation Studies of Olmesartan Medoxomil and Characterization of Its Major Degradation Products by LC-MS/MS, NMR, IR and TLC. Asian Journal of Pharmaceutical Analysis. 2015; 5(3): 119-25. doi.org/10.5958/2231-5675.2015.00019.8
27.    Thangabalan B, Salomi M, Sunitha N, Babu SM. Development of validated RP-HPLC method for the estimation of Itraconazole in pure and pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2013;3(4):119-23. doi.org/10.52711/2231-5675.2021.00031
28.    Sri KV, Anusha M, Reddy SR. A rapid RP-HPLC method development and Validation for the Analysis of Linagliptinin Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2015; 5(1):16-20. doi.org/10.5958/2231-5675.2015.00003.4
29.    Konidala SK, Penumala A, Mugada VK, Kamala GR. Development and validation of RP-HPLC method for simultaneous estimation of Paracetamol and Flupirtine Maleate. Asian Journal of Pharmaceutical Analysis. 2015; 5(2): 105-11. doi.org/10.5958/2231-5675.2015.00017.4
30.    Gandla K, Lalitha R, Bommakanti S, Suthakaran R, Pallavi K. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Albendazole and Praziqantel in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2015; 5(3): 115-8. doi.org/10.5958/2231-5675.2015.00018.6
31.    Ganji S, Satyavati D. Development and validation of RP-HPLC method for the analysis of Cobicistat and related impurities in bulk and pharmaceutical dosage forms. Asian Journal of Pharmaceutical Analysis. 2015; 5(1): 1-8. doi.org/10.5958/2231-5675.2015.00001.0
32.    Mangalagiri Y, Mamidala SS, Konidala SK. A simple and validated RP-HPLC method for the simultaneous determination of Ezetimibe and Fenofibrate in bulk and pharmaceutical dosage forms. Asian Journal of Pharmaceutical Analysis. 2015; 5(2): 93-9. doi.org/10.5958/2231-5675.2015.00015.0
33.    Israel DS, Ganji S, Kumar BV. A Rapid RP HPLC Method Development and Validation for the Analysis of Divalproex in Bulk and Pharmaceutical Dosage Forms. Asian Journal of Pharmaceutical Analysis. 2016; 6(1): 15-22. doi.org/10.5958/2231-5675.2016.00003.X
34.    Vanaja N, Preethi C, Manjunath SY, Pal K. Method development and validation for simultaneous estimation of telmisartan and chlorthalidone by RP-HPLC in pharmaceutical dosage form. Asian Journal of Pharmaceutical Analysis. 2015; 5(4): 171-7. doi.org/10.5958/2231-5675.2015.00027.7

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