“INNOVATIVE APPROACHES IN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR EVOGLIPTIN TARTRATE AND ITS MULTI-DRUG COMBINATIONS”
Main Article Content
Keywords
Diabetes mellitus, Evogliptin Tartrate, Metformin Hydrochloride, Analytical methods (HPLC, UV, HPTLC),
Abstract
As pharmaceutical formulations become more complex—especially in the management of type 2 diabetes—there is a growing need for advanced analytical techniques to accurately assess drug content. This work presents innovative strategies for the development and validation of analytical methods tailored to Evogliptin tartrate, both as a standalone compound and in fixed-dose combinations with other antidiabetic agents. Due to the absence of official pharmacopoeial methods for newer drugs like Evogliptin, novel approaches utilizing UV spectrophotometry, high-performance liquid chromatography (HPLC), and LC-MS were investigated. The methods were developed following ICH guidelines and rigorously validated for parameters such as specificity, linearity, accuracy, precision, and sensitivity. These validated methods are designed to ensure reliable quality control and regulatory compliance for Evogliptin-containing formulations, ultimately supporting the safety and therapeutic effectiveness of modern antidiabetic treatments.
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28. Chadalawada P, Velupla D, Challa A, Puvvala S, Khan I. RP-HPLC Analytical Method Development and Validation of Metformin Hydrochloride Tablets Assay. International Journal of Pharmaceutical and Biological Sciences. 2019;9(3):505-19.
29. Patel A, Kotadiya M, Shah B. Development and analytical method validation for simultaneous estimation of Evogliptin Tartrate and Metformin Hydrochloride in combine dosage form. Int. J. Pharma. l Qual. As. 2022;13(4):504-9.
30. Sireesha D, Ganesh K, Nikitha G, Vasudha B. Development and validation of UV spectrophotometric method for simultaneous estimation of metformin and glipizide in tablet dosage form. International Journal of Applied Pharmaceutical Sciences and Research. 2016 Jun 30;1(02):56-9.
31. Sen DB, Sen AK, Zanwar A, Balaraman R, Seth A. Determination of alogliptin benzoate and metformin hydrochloride in tablet dosage form by simultaneous equation and absorption ratio method.
32. Prasanna AC, Priyanka K. METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS DETERMINATION OF METFORMIN AND SAXAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC. International Journal of Pharmaceutical, Chemical & Biological Sciences. 2015 Jan 1;5(1).
33. Malgundkar SS, Mulla S. Validated HPTLC method for simultaneous determination of metformin hydrochloride and glibenclamide in combined dosage form. IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) e-ISSN. 2014:2278-3008.
34. Modi DK, Parejiya PB, Patel BH. A simple and sensitive HPTLC method for simultaneous determination of metformin hydrochloride and sitagliptin phosphate in tablet dosage form. Journal of Chemistry. 2013;2013(1):139561.
35. ICH, Q2B Validation of Analytical Procedure: Methodology, in: Proceeding of the International Conference on Harmonization, Geneva; 1996
2. Thakkar K, Patel K, Patel UB, Patel CN. Evogliptin tartrate a new drug of DPP-4 inhibitor: an overview. World Journal of Pharmaceutical Research. 2021 Mar 19;10(5):1921-9.
3. Gajjar D, Shah DA. Development of liquid chromatographic (LC) method for simultaneous estimation of novel anti diabetic drug Evogliptin and Metformin. Journal of Chemical Metrology. 2024 Jan 1;18(1). Diabetes Mellitus: A Review Chinmay D. Deshmukh1, 2* and Anurekha Jain
4. Diabetes Mellitus: A Review Chinmay D. Deshmukh1, 2* and Anurekha Jain
5. CDSCO, ―Evogliptin tartrate‖, February 2021.
6. Rathod HC, Desai SP. Review On Analytical Method For Quantitative Estimation Of Metformin Hydrochloride And Evogliptin Tartrate In Pharmaceutical Dosage Form. World Journal of Pharmaceutical Research Www. wjpr. net [Internet]. 2015;10.
7. PubChem [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. PubChem Compound Summary for CID 135395528; [cited 2025 Sept. 13].
8. Bailey CJ. Metformin: historical overview. Diabetologia. 2017 Sep;60(9):1566-76.
9. PubChem [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. PubChem Compound Summary for CID 14219, Metformin Hydrochloride; [cited 2025 Sept. 13].
10. Song JS, Lee DY, Shim H, Lee HJ, La S, Deuker SR, et al. A phase I, open-label, 2-part study to establish absolute bioavailability and the absorption, metabolism and excretion of evogliptin in healthy male subjects by a light-label approach. Drug Metab Pharmacokinet 2017;32:S78.
11. MFDS approval of a new, domestically-developed, oral antihyperglycemics agent [media release]. Ministry of Food and Drug Safety; 2015.
12. Lee DY, Chae HW, Shim HJ. In vitro evaluation of potential transporter-mediated drug interactions of evogliptin. Biopharm Drug Dispos 2017; 38:398-403. PUBMED | CROSSRE
13. Dong-A ST’s DPP-4 inhibitor SUGANON, got approved for diabetes in Korea, 2 oct 2015.
14. PubChem (135395528), ―Evogliptin tartrate ‖ March 2021.
15. Kikuchi M, Haneda M, Koya D, Tobe K, Onishi Y, Couturier A, Mimori N, Inaba Y, Goodman M. Efficacy and tolerability of vildagliptin as an addon to glimepiride in Japanese patients with type 2 diabetes mellitus. Diabetes research and clinical practice. 2010 Sep 1;89(3):216-23.
16. Bolli G, Dotta F, Colin L, Minic B, Goodman M. Comparison of vildagliptin and pioglitazone in patients with type 2 diabetes inadequately controlled with metformin. Diabetes, Obesity and Metabolism. 2009 Jun;11(6):589-95.
17. Alkem Laboratories Ltd; [Revised on 21st April 2020] [Accessed on 17th July 2023], Evogliptin.pdf (alkemlabs.com)
18. Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry. New Delhi; CBS publisher and distributors, 2002; 4: 279-300.
19. Chatwal GR, Anand SK. Instrumental methods of chemical analysis. 5th ed., Mumbai; Himalaya publishing house, 2002; 1: 2149-2184.
20. Shethi PD. HPLC-Quantitative analysis of Pharmaceutical Formulations. New Delhi; CBS publisher & distributors, 1997; 3: 59-63.
21. Patel K, Shah UA, Joshi H, Patel CN. Derivative spectrophotometric method development and validation for the estimation of evogliptin tartrate in pharmaceutical dosage form. Indian J of Pharmaceutical Education and Research. 2023 Jan 1;57(1):228-33.
22. Agrawal YP, Agrawal MY, Jadhav SB, Shinde RJ. Development and validation of novel UV spectrophotometric method for the determination of evogliptin tartarate in pharmaceutical dosage form. Indian Journal of Pharmaceutical Education and Research. 2020;54(4):1174-9.
23. Dange YD, Honmane SM, Bhinge SD, Salunkhe VR, Jadge DR. Development and validation of UV-spectrophotometric method for estimation of metformin in bulk and tablet dosage form. Indian journal of pharmaceutical education and research. 2017 Oct 1;51(4S): S754-60.
24. The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare the Indian Pharmacopeia commission, Ghaziabad, 2018; 7: 2544-2548.
25. British Pharmacopoeia, The department of Health, Social Service and public Safety, The British Pharmacopoeia Commission, 2003; 4: 1219-1220.
26. Karim R, Poly N, Banoo R. Development and validation of UV spectroscopic method for the determination of metformin hydrochloride in tablet dosage form. International journal of pharmaceutical sciences and research. 2012 Sep 1;3(9):3170.
27. Nikam N, Maru A, Jadhav A, Malpure P. Analytical method development and validation of metformin hydrochloride by using RP-HPLC with ICH guidelines. Int J Trend Sci Res Dev. 2019 Mar;3(3):415-9.
28. Chadalawada P, Velupla D, Challa A, Puvvala S, Khan I. RP-HPLC Analytical Method Development and Validation of Metformin Hydrochloride Tablets Assay. International Journal of Pharmaceutical and Biological Sciences. 2019;9(3):505-19.
29. Patel A, Kotadiya M, Shah B. Development and analytical method validation for simultaneous estimation of Evogliptin Tartrate and Metformin Hydrochloride in combine dosage form. Int. J. Pharma. l Qual. As. 2022;13(4):504-9.
30. Sireesha D, Ganesh K, Nikitha G, Vasudha B. Development and validation of UV spectrophotometric method for simultaneous estimation of metformin and glipizide in tablet dosage form. International Journal of Applied Pharmaceutical Sciences and Research. 2016 Jun 30;1(02):56-9.
31. Sen DB, Sen AK, Zanwar A, Balaraman R, Seth A. Determination of alogliptin benzoate and metformin hydrochloride in tablet dosage form by simultaneous equation and absorption ratio method.
32. Prasanna AC, Priyanka K. METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS DETERMINATION OF METFORMIN AND SAXAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC. International Journal of Pharmaceutical, Chemical & Biological Sciences. 2015 Jan 1;5(1).
33. Malgundkar SS, Mulla S. Validated HPTLC method for simultaneous determination of metformin hydrochloride and glibenclamide in combined dosage form. IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS) e-ISSN. 2014:2278-3008.
34. Modi DK, Parejiya PB, Patel BH. A simple and sensitive HPTLC method for simultaneous determination of metformin hydrochloride and sitagliptin phosphate in tablet dosage form. Journal of Chemistry. 2013;2013(1):139561.
35. ICH, Q2B Validation of Analytical Procedure: Methodology, in: Proceeding of the International Conference on Harmonization, Geneva; 1996
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Published
Sep 26, 2025
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How to Cite
Pratiti B Patel, Dr. Neha Tiwari, & Dr. Pragnesh Patani. (2025). “INNOVATIVE APPROACHES IN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR EVOGLIPTIN TARTRATE AND ITS MULTI-DRUG COMBINATIONS”. Journal of Population Therapeutics and Clinical Pharmacology, 32(7), 1660-1669. https://doi.org/10.53555/jthn2748
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Author Biographies
Pratiti B Patel
Department of Pharmaceutical Quality Assurance Khyati College of Pharmacy, Ahmedabad, Gujarat, India.
Dr. Neha Tiwari
Department of Quality Assurance, Khyati College of Pharmacy, Gujarat, India.
Dr. Pragnesh Patani
Department of Pharmacology, Khyati College of Pharmacy, Ahmedabad, Gujarat, India.
How to Cite
Pratiti B Patel, Dr. Neha Tiwari, & Dr. Pragnesh Patani. (2025). “INNOVATIVE APPROACHES IN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR EVOGLIPTIN TARTRATE AND ITS MULTI-DRUG COMBINATIONS”. Journal of Population Therapeutics and Clinical Pharmacology, 32(7), 1660-1669. https://doi.org/10.53555/jthn2748