Volume : 13, Issue : 09, September – 2026
Title:
DEVELOPMENT AND VALIDATION OF AN HPLC METHOD FOR DETERMINATION OF ANTIDIABETIC DRUG TRELAGLIPTIN IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS
Authors :
K. Jyothi*, Sravani, Veera raghava, Likitha Jangam, Sufiyan, Anil Rathod
Abstract :
A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Trelagliptin in bulk form and marketed formulations. Separation of Trelagliptin was successfully achieved on a Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 12-28mcg/mL for Trelagliptin. The correlation coefficient was found to be 0.9995 for Trelagliptin. The LOD and LOQ for Trelagliptin were found to be 5.004µg/mL and 15.164µg/mL respectively. The proposed method was found to be good percentage recovery for Trelagliptin, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.
Keywords: Trelagliptin, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.
Cite This Article:
Please cite this article in press K Jyothi et al., Development And Validation Of An Hplc Method For Determination Of Antidiabetic Drug Trelagliptin In Bulk And Marketed Pharmaceutical Dosage Forms.,. Indo Am. J. P. Sci, 2026; 13(09).
REFERENCES:
1. https://go.drugbank.com/drugs/DB15323
2. https://pubchem.ncbi.nlm.nih.gov/compound/Trelagliptin
3. https://en.wikipedia.org/wiki/Trelagliptin
4. R. Snyder, J. Kirkland, L. Glajch, Practical HPLC Method Development, john Wiley and sons International publication, II Edn., 2011.
5. S. Ashutoshkar, Pharmaceutical Drug Analysis 2nd Edn, New Age International Private Limited Publishers, 452-474, 2005.
6. H. Beckett and J.B. Stenlake, Practical Pharmaceutical Chemistry, 4th End. C.B.S. Publishers and Distributors’, New Delhi. 1-9, 157-167.
7. H.H. Williard, L.L. Merit, F.A. Dean, F.A. Settle, Instrumental Methods Of Analysis, 6th Edn, C.B.S. Publishers and Distributors, New Delhi.: 430-440, 495-504,529-545.
8. B.K. Sharma, Instrumental Methods of Chemical Analysis. GOEL Publishing House, Meerut: 286-300.
9. Instant notes on analytical chemistry by D. Kealey and P.J. Haines, © BIOS Scientific Publishers Limited, UK, 6-7, 2002.
10. Gurdeep R. Chatwal, Sham K. Anand, Instrumental methods of Chemical Analysis,5th edition, Himalaya Publishing House(Mumbai), P-2.566, 2005,.
11. M. E. Swartz, Journal of liquid chromatography, 28(7/8), 1253-1263(2005).
12. Journal of Chromatography .B, Analytical Technologies in the Biomedical and life Sciences. 2008 March 1; 863(2): 258-265. Published on Jan 18 2008.
13. International Conference on Harmonization, Harmonized Tripartite Guideline. Validation of Analytical Procedures. Text and Methodology. Q2 (R1). November 2005.
14. International Conference on Harmonization (ICH). Validation of Analytical Methods: Definitions and Terminology. ICH Q2A. 1994.
15. J. M. Green, a practical guide to analytical method validation, anal. Chem. News & features, pp. 305a–309a, 1 May 1996.
16. P. A. Winslow and r. F. Meyer, defining a master plan for the validation of analytical methods, j. Validation technology, pp. 361–367, 1997.
17. Aoac peer-verified methods program, manual on policies and procedures, Arlington, Va., USA (1998).
18. R. Patil: J of Chromatographia, 67, 575, (2008).
19. Baht and Leena: J of Liq. Chrom., 30, 309, (2007).
20. H.H. Williard, L.L. Merit, F.A. Dean and F.A. Settle, Instrumental methods of analysis, 7th edition, C.B.S. Publishers, New Delhi, 2002.
21. GN Menon, LB White, Department of Analytical Research, Abbott Laboratories, (pub med-index for MEDLINE).
22. Food and Drug Administration (FDA), “Analytical Procedures and Methods Validation: Chemistry, Manufacturing and Controls Documentation;” Federal Register (Notices), Vol: 65 (169), 52776–52777, 2000.
23. Vibha G et al., Development and validation of HPLC method – a review. International Research Journal of Pharmaceutical and Applied Sciences. 2012, 2(4), 22-23.
24. Bliesner DM. In: Validating Chromatographic Methods. John Wiley & sons Inc. 2006, 88-92.
25. Development and validation of HPLC method – A Review, Vibha Gupta et al, International Research Journal of Pharmaceutical and Applied Sciences, 2012; 2(4):17-25.
26. A Review: HPLC Method Development and Validation, Santosh Kumar Bhardwaj *et al. International Journal of Analytical and Bioanalytical Chemistry, accepted 20 November 2015.
27. Method Development: A Guide to Basics Quantitative & Qualitative HPLC, LC, GC chromacademy.
28. Lalit V Sonawane* Bioanalytical Method Validation and Its Pharmaceutical Application- A Review Pharmaceutica Analytical Acta 2014, 5:3Center for Drug Evaluation and Research (CDER) Reviewer Guidance.
29. Validation of Analytical Procedures: Methodology. ICH-Guidelines Q2B, Geneva. 1996, 11. (CPMP/ICH/281/95).
30. ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology.
31. Madhavi Arram, Srinivas Medidi and Gupta Niraj, Development and validation of simplified RP-HPLC method for quantification of Trelagliptin in tablet dosage form: Greenness analysis using AGREE penalties, International Journal of Zoological Investigations, Vol. 10, No. 2, 425-436 (2024).
32. Shaik Naazneen, RP-HPLC Method Development and Validation for the Estimation of Trelagliptin in Pure and Pharmaceutical Dosage Form, International Journal of Science and Research (IJSR), Volume 13 Issue 7, July 2024, Pages: 1400-1404.