Volume : 12, Issue : 06, June – 2025

Title:

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TELBIVUDINE IN API FORM AND MARKETED FORMULATION

Authors :

Juveriya Fatima Siddiqui*, Syeda Hafsa Fatima, Adiba Erum, Syeda Khadija Imad, Neha Tabassum, Anas

Abstract :

A new, simple, rapid, precise, accurate and reproducible stability indicating RP-HPLC method for estimation of Telbivudine in bulk form and marketed formulation. Separation of Telbivudine was successfully achieved on a Symmetry ODS C18 (4.6 x 250mm, 5m) column in an isocratic mode of separation utilizing Acetonitrile: Methanol in the ratio of 80:20% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 272nm. 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 10-50mcg/mL for Telbivudine. The correlation coefficient was found to be 0.999 for Telbivudine. The LOD and LOQ for Telbivudine were found to be 1.1µg/mL and 3.2µg/mL respectively. The proposed method was found to be good percentage recovery for Telbivudine, 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. For the stability study the drug was exposed to various stress conditions such as Acidic, Basic, Oxidative, Thermal, and Photolytic as per recommendations of ICH Guidelines.
Keywords: Telbivudine, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.

Cite This Article:

Please cite this article in press Juveriya Fatima Siddiqui et al., Stability Indicating Rp-Hplc Method Development And Validation For The Estimation Of Telbivudine In Api Form And Marketed Formulation.., Indo Am. J. P. Sci, 2025; 12(07).

Number of Downloads : 10

References:

1. https://go.drugbank.com/drugs/DB01265
2. https://pubchem.ncbi.nlm.nih.gov/compound/Telbivudine
3. https://en.wikipedia.org/wiki/Telbivudine
4. Sharma BK. Instrumental methods of chemical analysis, Introduction to analytical chemistry, 23th ed .Goel publishing house Meerut, 2004, P12-23.
5. H.H. Willard, L.L. Merritt, J.A. Dean, F.A. Settle. Instrumental methods of analysis, 7th edition, CBS publishers and distributors, New Delhi. 1986, P.518-521, 580-610.
6. John Adamovies, Chromatographic analysis of pharmaceutical, Marcel Dekker Inc. New York, 2nd Ed, P.74, 5-15.
7. Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of chemical analysis, 5th edition, Himalaya publishing house, New Delhi, 2002, P.1.1-1.8, 2.566-2.570
8. D. A. Skoog. J. Holler, T.A. Nieman. Principle of instrumental analysis, 5th edition, Saunders college publishing, 1998, P.778-787.
9. Skoog, Holler, Nieman. Principals of instrumental analysis 5th Ed, Harcourt Publisher’s international company, 2001, P.543-554.
10. William Kemp. Organic spectroscopy, Palgrave, New York, 2005, P.7-10, 328-330
11. P.D. Sethi. HPLC: Quantitative analysis pharmaceutical formulations, CBS publishers and distributors, New Delhi (India), 2001, P.3-137.
12. Michael E, Schartz IS, Krull. Analytical method development and validation. 2004, P. 25-46.
13. R. Snyder, J. Kirkland, L. Glajch. Practical HPLC method development, 2nd Ed, a Wiley international publication, 1997, P.235, 266-268, 351-353.653-600.686-695.
14. Basic education in analytical chemistry. Analytical science, 2001:17(1).
15. Method validation guidelines international conference on harmonization; GENEVA; 1996
16. Berry RI, Nash AR. Pharmaceutical process validation, Analytical method validation, Marcel Dekker Inc. New work, 1993; 57:411-28
17. Anthony C Moffat, M David Osselton, Brian Widdop. Clarke’s analysis of drugs and poisons, Pharmaceutical press, London, 2004, P.1109-1110, 1601-1602.
18. Klaus Florey, Analysis profile of drugs substances, Academic press, New York, 2005, P.406-435.
19. P.N. Arora, P.K. Malhan. Biostatistics, Himalaya Publishers house, India, P.113, 139-140,154.
20. L. R. Snyder, J.J. Kirkland, and J. W. Dolan, Introduction to Modern Liquid Chromatography, John Wiley & Sons, New York, 2009.
21. M.W. Dong, Modern HPLC for practicing scientists. Wiley, 2006.
22. L. R. Snyder, J.J. Kirkland, and J. L. Glajch, Practical HPLC Method Development, John Wiley & Sons, New York, 1997.
23. S. Ahuja and H. T. Rasmussen (Ed), HPLC Method Development for Pharmaceuticals, Academic Press, 2007.
24. S. Ahuja and M.W. Dong (Ed), Handbook of Pharmaceutical Analysis by HPLC, Elsevier/Academic Press, 2005.
25. Y. V. Kazakevich and R. LoBrutto (ed.), HPLC for Pharmaceutical Scientists, Wiley, 2007.
26. U. D. Neue, HPLC Columns: Theory, Technology, and Practice, Wiley-VCH, New York, 1997.
27. M. C. McMaster, HPLC, a practical user’s guide, Wiley, 2007.
28. Doserge, Wilson and Gisvold’s text book of organic medicinal and pharmaceutical chemistry, 8th Ed, Lippincott Company, 1982, P.183-197.
29. Snyder, Lloyd R.; Dolan, John W. (2006). High-Performance Gradient Elution: The Practical Application of the Linear-Solvent-Strength Model. Wiley Interscience.
30. Giddings, J. Calvin (1965) Dynamics of Chromatography, Part I. Principles and Theory. Marcel Dekker, Inc., New York. p. 281.
31. K., Robards (1994). Principles and practice of modern chromatographic methods. Haddad, P. R., Jackson, P. E. Amsterdam: Elsevier/Academic Press.
32. ICH Guidance. Validation of analytical methods – definition and terminology. Q2A. Geneva: International Conference on Harmonization. Nov 2005.
33. ICH Guidance, Validation of analytical procedures – methodology. Q2B. Geneva: International Conference on Harmonization. Nov 2005.
34. B. Raj Kumar1* Dr. K. V. Subrahmanyam2, A New Validated Stability-Indicating RP-HPLC Method for the Determination of Telbivudine, Journal of Global Trends in Pharmaceutical Sciences, JGTPS/ 5(3)-(2014), 1827- 1832.
35. M. Gnana Chandrika*, M. Vamsi Krishna and K. Padmalatha, Development and Validation of Rp-Hplc Method for the Estimation of Telbivudine in Bulk Drugs and Pharmaceutical Formulations, Journal of Global Trends in Pharmaceutical Sciences, 2020; 11 (3): 8177 – 8180.