Volume : 12, Issue : 04, April – 2025

Title:

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC FOR DETERMINATION OF ANTIDIABETIC DRUG

Authors :

Priyanka P. Kurhale, Sonali M. Mundhe, Dr. Kailash R. Biyani

Abstract :

This study reports the method development and validation for antidiabetic drugs. A novel, simple, rapid, specific, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method has been developed and validated according to ICH guidelines. The validation encompassed assessments of linearity, accuracy, precision, limits of detection (LOD) and quantitation (LOQ), selectivity, range, stability, and robustness. Diabetes mellitus represents a major global health concern and frequently co-occurs with other conditions, necessitating comprehensive management. Various techniques, including UV spectrophotometry and HPLC, are employed for the simultaneous quantification of multiple drugs in dosage forms. These methods offer advantages such as high specificity, accuracy, linearity, and speed, making them powerful and reliable tools. The pharmaceutical industry relies heavily on quantitative chemical analysis to ensure that both raw materials and finished products meet stringent quality specifications.
Keywords: Validation, RP-HPLC method, anti-diabetic drug, analytical method.

Cite This Article:

Please cite this article in press Priyanka P. Kurhale et al., Analytical Method Development And Validation Of RP-HPLC For Determination Of Antidiabetic Drug.,, Indo Am. J. P. Sci, 2025; 12(04).

Number of Downloads : 10

References:

1. Nusrat K. Shaikh, Rakeshkumar Jat, and Jitendra O. Bhangle , ” Development and validation of stability indicating RP-HPLC and UV method for simultaneous quantitation of sitagliptin and sitagliptin phosphate in combination,” American Journal of Pharmacy Research 2020, 10(6): 2249-338.
2. S. Adsul, J.S. Bidkar, Sunil Harer, and G.Y. Dama, “RP-HPLC Method Development and Validation for Simultaneous Estimation for Metformin and Sitagliptin in Bulk and Tablet Formulation,” International Journal of Chem Tech Research 2018, (11) 11, 2455-9555.
3. Priya Sadapha, Kavita Dhamak, ”High-Performance Liquid Chromatography (HPLC) Method Development and Validation” International Journal of Pharmaceutical Sciences Review and Research, Research,2022(2)74, 23-29
4. Rushikesh Bacchav, Piyush Bacchav, Mayur Bhamre, Ruchita Bacchav, Ganesh Sonawane, Kajal Pansare, and Dhananjay Patil, “Review of High-Performance Liquid Chromatography and its Applications,” Journal of Pharmacy and Pharmaceutical Sciences, 2023, 12(3), 30-44.
5. J. Anudeepa, R. Manavalan, R. Venkata, “Development of UV Spectrophotometric Method for Sitagliptin in Bulk and Pharmaceutical Formulation,” International Journal of Science, Engineering, and Technology, 2015, 3(5): 1352-1354.
6. C. BalaSekaran & A. Prameela Rani, “Development and validation of a spectrophotometric method for the determination of DPP-4 inhibitor, sitagliptin, in its pharmaceutical preparations,” Ecletica Quimica, vol. 35, no. 3, São Paulo, Sept. 2010.
7. Jain Pritam, Chaudhari Amar, Desai Bhargav, Patel Shani, Patel Santsara, Shimpi Hiren, ShimpiHiren,“Development and validation of first-order derivative UV-spectrophotometric method for determination of sitagliptin in bulk and formulation,” International Journal of Drug Development and Research, Int. J. Drug Dev. & Res., Oct-Dec 2011, 3(4): 195
8. N. S. Disha and Dr. B. M. Gurupadhayya, “Spectrophotometric determination of Sitagliptin Phosphate in bulk and pharmaceutical formulations,” IJISET – International Journal of Innovative Science, Engineering & Technology, Vol. 2, Issue 7, July 2015, 702-709.
9. Ramakrishna Nirogi, Vishwottam Kandikere, Koteshwara Mudigonda, Prashanth Komarneni, Raghupath Sialeti, and Rajeshkumar Boggavarapu “Sensitive liquid chromatography-tandem mass spectrometry method for the quantification of sitagliptin, a DPP-4 inhibitor, in human plasma using liquid–liquid extraction,” Biomed. Chromatography., (2008) 22: 214–222.
10. Wei Zeng, Yang Xu, Marvin Constanzer, and Eric J. Woolf, “Determination of sitagliptin in human plasma using protein precipitation and tandem mass spectrometry,” Journal of Chromatography , Volume 878, Issue 21, 1 July 2010, Pages 181–182.
11. N. N.Monila, Ravi Pratap Pulla, Harshini Shabad, V. V.Swathi, Rajasekhar, A. Ramesh, B. Koti Reddy & B. Umashankar, New Extractive Method Development of Sitagliptin Phosphate in API and Its Unit Dosage Forms by Spectrophotometry,” IOSR Journal of Pharmacy and Biological Sciences, Volume 1, Issue 6 (July-August 2012), PP 37-40.
12. Hiren Havelikar, Naitik Soni, Purvi Shah, Kirti Patel, Kalpana Patel, and Tejal Gandhi, “Spectrofluorimetric Method for Determination of Sitagliptin Phosphate in Formulation and Spiked Human Urine,” International Journal of Analytical and Bioanalytical Chemistry, received 31 August 2012; accepted 17 October 2012.
13. Karimulla S K, Vasanth P M, Ramesh T, Ramesh M, “Method development and validation of sitagliptin and metformin using reverse-phase HPLC method in bulk and tablet dosage form,” Der Pharmacia Lettre, 2013, 5(5): 168-174.
14. Sachin L. Patil, Jayant R. Bhinge, and Chetan M. Bhagat, “Development and Validation of Stability Indicating RP HPLC Method for Simultaneous Determination of Sitagliptin and Metformin in Tablet Dosage Form,” International Journal of Research in Pharmaceutical and Biomedical Sciences (IJRPBS), Apr-Jun 2013; Vol. Vol.4(2): 590–596.
15. Yaraveda YaravedaLathareddy & Naidu Srinivasa Rao, “Stability-indicating RP-HPLC method and its validation for analysis of metformin & sitagliptin in bulk and pharmaceutical dosage form, form”World Journal of Pharmacy and Pharmaceutical Sciences, Volume 2, Issue 5, 3691-3709.
16. Srinivasa Reddy, Imran Ahmed, Iqbal Ahmad, Arindam ArindamMukhopadhyay and Saral Thangam, “Development and Validation of a Method for Simultaneous Estimation of Metformin and Sitagliptin in Human Plasma by LC-MS-MS and Its Application in a Bioequivalence Study, Study”,Journal of Chromatographic Science 2015;1–8.
17. Kumar R, Saha P, Kumar Y, Sahana S, Dubey A, Prakash O. A Review on Diabetes Mellitus: Type 1 & Type 2. World Journal of Pharmacy and Pharmaceutical Sciences. (2020)
18. Arneth B, Arneth R, Shams M. Metabolomics of type 1 and type 2 diabetes. International Journal of Molecular Sciences. (2019) May 18;20(10):2467.
19. Diabetes statistics 2023 [Internet]. Available from https://www.singlecare.com/blog/news/diabetes-statistics/. (2023)
20. Sadaphal P, Dhamak K. Review article on high-performance liquid chromatography (HPLC) method development and validation. Int J Pharm Sci Rev Res [Internet]. (2022); 23–9
21. Sandeep Pawar et al., International Journal of Pharmaceutical Sciences & Medicine (IJPSM), Vol. 7, Issue 10, October 2022, pp. 6-29.
22. International Journal of Pharmaceutical Sciences & Medicine (IJPSM), CDER Reviewer Guidance: Validation of Chromatographic Methods, Nov. 1994.
23. Kumar R, Saha P, Kumar Y, Sahana S, Dubey A, Prakash O. A Review on Diabetes Mellitus: Type 1 & Type 2. World Journal of Pharmacy and Pharmaceutical Sciences. (2020)
24. Arneth B, Arneth R, Shams M. Metabolomics of type 1 and type 2 diabetes. International Journal of Molecular Sciences. (2019) May 18;20(10):2467.
25. Diabetes statistics 2023 [Internet]. Available from https://www.singlecare.com/blog/news/diabetes-statistics/. (2023)
26. Daniel Ducker, Chris Easley, and Peter Kirkpatrick (2007). Sitagliptin. Nat. Rev. Drug. Discov. 6:109-110. doi.org/10.1038/nrd2245
27. Prashant BM, Rishikesh VA, Rajesh JO. Antidiabetic Drugs: An Overview. Int J Ph and Ch Sc. 2012;1(1):301-6.
28. Balamurugan K, Kirtimaya M, Suresh R. Optimization of the simultaneous determination of sitagliptin and metformin in human plasma by a rapid HPLC method. J Glob Pharma Technol. 2018;10(12):7-12.
19. Ramalingam P, Udaya BV, Padmanabha RY, Vinod KK. Stability-indicating RP-HPLC method for the simultaneous determination of sitagliptin and simvastatin in tablets. Ind J Pharm Sci. 2014;76(5):407.
20. Manasa S, Dhanalakshmi K, Reddy NG, Sreenivasa S. Method development and validation of dapagliflozin in API by RP-HPLC and UV-spectroscopy. Int J Pharm Sci Drug Res 2014;6(3):250-2.
21. Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin, a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab 2013;15(9):853-62. The combination of these studies underscores the importance of advanced analytical techniques in pharmacology. As new medications continue to emerge, the development and validation of reliable methods for their quantification remain critical for ensuring safety and efficacy in patient care.