Author(s):
Hiral S. Popaniya, Dinesh K. Dangar, Chintankumar J. Tank
Email(s):
hpopaniya@gmail.com , dineshdangar@gmail.com , chintankumartank@gmail.com
DOI:
10.52711/2231-5675.2024.00049 
Address:
Hiral S. Popaniya1*, Dinesh K. Dangar2, Chintankumar J. Tank3
1Research Scholar, School of Pharmacy, Dr. Subhash University, Junagadh (362001), Gujarat, India.
2Associate Professor, School of Pharmacy, Dr. Subhash University, Junagadh (362001), Gujarat, India.
3Professor, School of Pharmacy, Dr. Subhash University, Junagadh (362001), Gujarat, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 4,
Year - 2024
ABSTRACT:
Dapagliflozin and linagliptin are two oral antidiabetic drugs that are commonly used in combination to treat type 2 diabetes. Dapagliflozin is a sodium-glucose cotransporter 2(SGLT2) inhibitor that works by increasing the excretion of glucose in the urine. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by increasing the levels of incretin hormones, which stimulate the pancreas to produce more insulin and reduce the production of glucagon. There are a variety of analytical methods that can be used to estimate the concentration of dapagliflozin and linagliptin in dosage forms. These methods include high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS/MS), and high-performance thin-layer chromatography (HPTLC). This review provides an overview of the different analytical methods that have been developed for the estimation of dapagliflozin and linagliptin in pharmaceutical dosage forms. The focus of the review is on the development and validation of these methods, as well as their application to the analysis of pharmaceutical formulations.
Cite this article:
Hiral S. Popaniya, Dinesh K. Dangar, Chintankumar J. Tank. A Concise Review Based on Analytical Methods for Estimation of Dapagliflozin and Linagliptin in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2024; 14(4):275-2. doi: 10.52711/2231-5675.2024.00049
Cite(Electronic):
Hiral S. Popaniya, Dinesh K. Dangar, Chintankumar J. Tank. A Concise Review Based on Analytical Methods for Estimation of Dapagliflozin and Linagliptin in Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2024; 14(4):275-2. doi: 10.52711/2231-5675.2024.00049 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2024-14-4-13
REFERENCE:
1. Dhillon S, Dapagliflozin: A Review in Type 2 Diabetes. Drugs. 2019 Jul; 79(10): 1135-1146. DOI: 10.1007/s40265-019-01148-3
2. Jabbour S, Durability of response to dapagliflozin: a review of long-term efficacy and safety. Current Medical Research and Opinion. 2017 Sep; 33(9): 1685-1696. DOI: 10.1080/03007995.2017.1354822
3. Aswini R, Eswarudu MM, Srinivasa BP, A Review on Analytical Methods for Estimation of Dapagliflozin and Saxagliptin in Bulk and in Pharmaceutcal Dosage Forms. International Journal of Research in Pharmaceutical Chemistry and Analysis. 2018; 8(3): 460-468.
4. Taskinen M.R, Rosenstock J, Tamminen I, Kubiak, R, Patel S, Dugi, K.A, et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. diabetes, obesity, and metabolism. 2011; 13: 65-74.
5. Del P.S, Barnett A.H, Huisman H, Neubacher D, Woerle H.J, Dugi K.A, Effect of linagliptin monotherapy on glycaemic control and markers of β-cell function in patients with inadequately controlled type 2 diabetes: a randomized controlled trial. diabetes, obesity, and metabolism. 2011; 13: 258-267.
6. Kawamori R, Inagaki N, Araki E, Watada H, Hayashi N, Horie Y, et al. Linagliptin monotherapy provides superior glycaemic control versus placebo or voglibose with comparable safety in Japanese patients with type 2 diabetes: a randomized, placebo and active comparator-controlled, double-blind study. diabetes, obesity, and metabolism. 2012; 14: 348-357.
7. Gomis R, Owens D.R, Taskinen M.R, Del P.S, Patel S, Pivovarova A, et al. long-term safety and efficacy of linagliptin as monotherapy or in combination with other oral glucose-lowering agents in 2121 subjects with type 2 diabetes: up to 2 years exposure in 24- week phase III trials followed by a 78-week open-label extension. International Journal of Clinical Practice. 2012; 66: 731-740.
8. Gomis R, Espadero R.M, Jones R, Woerle H.J, Dugi K.A, Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type 2 diabetes: a randomized, double-blind, placebo-controlled study. diabetes, obesity, and metabolism. 2011; 13: 653-661.
9. Taskinen M.R, Rosenstock J, Tamminen I, Kubiak R, Patel S, Dugi K.A, et al. Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study diabetes, obesity, and metabolism. 2011; 13: 65-74.
10. Deacon, C.F, Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. diabetes, obesity, and metabolism. 2011; 13: 7-18.
11. National library of medicine. Dapagliflozin [Image on internet] Available from:https://pubchem.ncbi.nlm.nih.gov/compound/Dapagliflozin
12. Linagliptin—A Novel Dipeptidyl Peptidase Inhibitor for Type 2 Diabetes Therapy [Image on internet] Available from: https://www.researchgate.net/figure/Chemical-structure-of linagliptin_fig1_230645845
13. U.S. Food and drug Administration https://www.fda.gov/drugs/development-approval-process-drugs/drug-approvals-and-databases
14. Drug bank online. Dapagliflozin available from:https://go.drugbank.com/drugs/DB06292
15. National library of medicine availalble from https://pubchem.ncbi.nlm.nih.gov/compound/Linagliptin
16. Mante GV, Gupta KR, Hemke AT. Estimation of dapagliflozin from its tablet formulation by UV-spectrophotometry. Pharm Methods. 2017 Jul 1; 8(2): 102-7.
17. Karuna PC, China E, Rao MB. Unique UV spectrophotometric method for reckoning of Dapagliflozin in bulk and pharmaceutical dosage forms. Journal of Chemical and Pharmaceutical Research. 2015; 7(9): 45-9.
18. Debata J, Kumar S, Jha SK, Khan A. A New RP-HPLC method development and validation of dapagliflozin in bulk and tablet dosage formInternational Journal of Drug Development and Research. 2017; 9(2): 48-51.
19. Mante G, Hemke A, Umekar M. RP-HPLC Method for Estimation of Dapagliflozin from its Tablet. International Journal of Chemtech Research. 2018; 11(1): 242-248.
20. Sanagapati M, Dhanalakshmi K, Reddy NG, Sreenivasa S. Development and Validation of stability- Indicating RP-HPLC method for determination of Dapagliflozin. Journal of Advanced Pharmacy Education & Research. 2014; 4(3): 350-353.
21. Basha S, Sravanthi P. Development and validation of dapagliflozin by reversed-phase high-performance liquid chromatography method and it’s forced degradation studies. Asian Journal of Pharmaceutical and Clinical Research. 2017; 10(11):101-5.
22. Sanagapati M, Dhanalakshmi K, Reddy NG, Sreenivasa S. Method development and validation of dapagliflozin in API by RP-HPLC and UV-spectroscopy. International Journal of Pharmaceutical Sciences and Drug Research. 2014; 6(3): 250-252
23. Sarkar S, Patel V. Method development and validation of dapagliflozine drug in bulk and tablet dosage form by RP-HPLCInternational Journal of Pharma Research and Health Sciences. 2017; 5(4):1755-9.
24. Verma MV, Patel CJ, Patel MM. Development and stability indicating HPLC method for dapagliflozin in API and pharmaceutical dosage form. International Journal of Applied Pharmaceutics. 2017; 9(5): 33-41.
25. Suma BV, Deveswaran R, Premnath SH. A new high-performance thin layer chromatographic method development and validation of dapagliflozin in bulk and tablet dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2019; 11: 58-63.
26. Khagga B, Thaneeru S, Samreen B, Mogili S. RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation. Archives of Pharmacy Practice. 2022; 12(4): 106-10.
27. Bhavyasri K, Surekha T, Sumakanth M. A Novel Method Development and Validation of Dapagliflozin and Metormin Hydrochloride using Simultaneous Equation Method by UV–Visible Spectroscopy in Bulk and Combined Pharmaceutical Formulation including Forced Degradation Studies. International Journal of Pharmaceutical Sciences and Research. Sci Res. 2020; Aug 1; 12(8): 1100-5.
28. Jani S, Shukla R, Patel P, Mehta B, Detholia K. Quantitative estimation of sitagliptin and dapagliflozinpropanediol monohydrate in synthetic mixture using 1st order derivative spectroscopy simultaneous spectrophotometric analysis. International Journal of Pharmaceutical Chemistry and Analysis. 2022; 9(1): 28-34.
29. Manasa M, Aanandhi VM. Stability indicating simultaneous method development and validation of dapagliflozin and saxagliptin by RP-HPLC. Research Journal of Pharmacy and Technology. 2021; 14(2): 1045-9.
30. Patel YD, Patel PR, Bhatt J, Mehta B, Detholia K. Quantitative computation and stability evaluation of phase III composition comprising sitagliptin and dapagliflozinpropanediol monohydrate by RP-HPLC. Journal of Applied Pharmaceutical Science. 2022; 12(06):148–155.
31. Boggula N, Pandiyan PS. Development and validation of RP-HPLC method for the simultaneous estimation of dapagliflozin and saxagliptin in bulk and pharmaceutical dosage forms. International Journal of Pharmaceutical Sciences and Research. 2021; 12(1): 314-320.
32. Kommineni V, Chowdary KP, Prasad SV. Development and validation of a new HPLC method for the simultaneous estimation of saxagliptine and dapagliflozin and its application in pharmacokinetic studies. International Research Journal of Pharmacy and Medical Sciences. 2018; 1 (6).
33. Gundala A, Prasad KV, Koganti B. Application of quality by design approach in RP-HPLC method development for simultaneous estimation of saxagliptin and dapagliflozin in tablet dosage form. Brazilian Journal of Pharmaceutical Sciences. 2019.
34. Vankalapati KR, Alegete P, & Boodida S. Stability-indicating HPLC method development and validation for simultaneous estimation of metformin, dapagliflozin, and saxagliptin in bulk drug and pharmaceutical dosage form. Biomedical Chromatography. 2022; 36 (7): 5384
35. VinuthaKommineni, K.P.R. Chowdary, S.V.U.M. Prasad. Formulation of Dapagliflozin and Saxagliptin Tablets and In vitro Evaluation by RP-HPLC Method. Asian Journal of Pharmaceutical Analysis. 2019; 9(2): 93-98. doi: 10.5958/2231-5675.2019.00018.8
36. Sayali S. More, Sandeep S. Sonawane, Santosh S. Chhajed, Sanjay J. Kshirsagar. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Saxagliptin and Dapagliflozin in Tablets. Asian Journal of Pharmacy and Technology. 2018; 8 (3): 145-148. doi: 10.5958/2231-5713.2018.00023.5
37. PriyaBarbude, MukundTawar, Prashant Burange. Method Development using a UV Visible Spectrophotometer for the Simultaneous Estimation of Metformin (MET), Saxagliptin (SXG), and Dapagliflozin (DGF) in Marketed Formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(4): 243-7. doi: 10.52711/2231-5675.2022.00039
38. Banik S, Kaisar M, Hossain M. S. Development and Validation of a Simple and Rapid UV Spectrophotometer Method for Assay of Linagliptin in Bulk and Marketed Dosage FormIndian Journal of Novel Drug Delivery. 2013; 5(4): 221-224
39. Deepika J, Bhavana S, Archana R, Nidhi S. Analytical Method Development and Validation of UV-Visible Visible Spectrophotometric Method for the Estimation of Linagliptin, Global Journal of Nanomedicine. 2021; 5(5): 555671.
40. Amruta D, Varsha T, RajashriW, Development and Validation of a Simple and Rapid UV Spectrophotometeric Method for Linagliptin in Bulk and Marketed Dosage Form, Der Pharma Chemica. 2022, 14(2): 23-26
41. Manish M, Govinda V, Analytical method development and validation for determination of linagliptin in bulk and dosage form by UV Spectroscopy, International Journal of Emerging Technologies and Innovative Research. 2018; 5 (7).
42. Amar G, Ravindranath B, Pramod N, Validated UV- Spectroscopic estimation of Linagliptin Concentration in Bulk and Dosage form, Research Journal of Pharmacy and Technology. 2016; 9(5).
43. Zubair M D, Balaram, V, Gajula, R. RP-HPLC method development and validation of and pharmaceutical dosage form method development and validation of Linagliptin in bulk drug and pharmaceutical dosage form. Der Pharmacia Sinica. 2014; 5 (5): 123-130.
44. Rajbangshi J C, Alam M M, Hossain M S, Islam M S, Rouf A S. Development and validation of a RP-HPLC method for quantitative analysis of Linagliptin in bulk and dosage forms. Dhaka University Journal of Pharmaceutical Sciences. 2018; Dec 4; 17(2): 175-82.
45. K. Vijaya Sri, M. Anusha, S. Ravinder Reddy. 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: 10.5958/2231-5675.2015.00003.4
46. Sara S. M, Eman I. El-Kimary, Dalia A. Hamdy, Magda A. Barary, Stability-Indicating HPLC-DAD Method for the Determination of Linagliptin in Tablet Dosage Form: Application to Degradation Kinetics. Journal of Chromatographic Science. 2016; 54 (9) 1560–1566, DOI: https://doi.org/10.1093/chromsci/bmw103
47. Shafi M S, Begum A, Saradhi N D. Bioanalytical method development and validation of linagliptin in plasma through LC-MS/MS. International Journal of Bioassays. 2014; 3: 3146-51.
48. Sumit S. S, Padmanabh B D, Israr Shaikh, Development and Validation of Novel Stability-Indicating RP-HPLC Method for Determination of Linagliptin. International Journal of Pharmaceutical Research. 2020; 19(1).
49. Rathore UB, Goyal PK. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Empagliflozin and Linagliptin in Solid Dosage Forms. European Journal of Molecular & Clinical Medicine. 2020; 7(1): 4666-73.
50. Vemula P, Dodda D, Balekari U, Panga S, Veeresham C. Simultaneous determination of linagliptin and metformin by reverse phase-high performance liquid chromatography method: An application in quantitative analysis of pharmaceutical dosage forms. JAdv Pharm Technol Res. 2015; 6(1):
51. Saroj Gajare, Amar Zalte, Ravindra B. Saudagar. Simultaneous Spectrophotometric Determination of Linagliptin and Metformin Hydrochloride in Combined Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2017; 7(2): 79-83. doi: 10.5958/2231-5675.2017.00013.8
52. Saroj Gajare, Vedantika Das, Ashwini Sambherao, Amar Zalte, Ravindra B. Saudagar. Development and Validation of Linagliptin and Metformin hydrochloride in Bulk and Combined Tablet Dosage Form by using UV Spectrophotometric Method. Asian Journal of Pharmaceutical Analysis. 2017; 7(2): 141-144. doi: 10.5958/2231-5675.2017.00022.9
53. Jadhav SB, Reddy PS, Narayanan KL, Bhosale PN. Development of RP-HPLC, stability indicating method for degradation products of linagliptin in presence of metformin HCl by applying 2 level factorial design; and identification of impurity-VII, VIII and IX and synthesis of impurity-VII. Scientiapharmaceutica. 2017; 85(3): 25.
54. Sachin S. Rane, Rajesh Y. Chaudhari, Vijay R. Patil, Lokesh G. Barde, Development and validation of UV spectrophotometric method for simultaneous estimation of Empagliflozin and Linagliptin in bulk drugs and pharmaceutical dosage form, Doctrines of Integrative Medicine, Pharmacy and Science. 2021; 1(1): 44-54.
55. Ceema Mathew, Sunayana Varma. Green Analytical Methods based on Chemometrics and UV spectroscopy for the simultaneous estimation of Empagliflozin and Linagliptin. Asian Journal of Pharmaceutical Analysis. 2022; 12(1): 43-8. doi: 10.52711/2231-5675.2022.00008
56. Unade TR, Pawar A. New validated Stability-indicating RP-HPLC method for the Simultaneous determination of Metformin hydrochloride, Linagliptin and Empagliflozin in bulk and pharmaceutical dosage form. Int J App Pharm. 2022; 14(2): 68-76.
57. Ishita M. Patel1, Usmangani K. Chhalotiya, Harsha D. Jani, Devansh Kansara, Hetaben M. Kachhiya and Dimal A. Shah, Simultaneous quantification of empagliflozin, linagliptin and metformin hydrochloride in bulk and synthetic mixture by RP–LC method, Future Journal of Pharmaceutical Science. 2021; 7: 182.
58. T. Naga Ravi Kiran, P. Parvathi, J.N. Suresh Kumar. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Linagliptin, Empagliflozin and Metformin in Solid Dosage FormsAsian Journal of Pharmaceutical Analysis. 2020; 10(3): 117-124. doi: 10.5958/2231-5675.2020.00021.6