28.Issue 08 august 24 - INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES

Volume : 11, Issue : 08, August – 2024

Title:

DEVELOPMENT AND VALIDATION FOR THE METHOD SIMULTANEOUS DETERMINATION OF DOLUTIGRAVIR AND LAMIVUDINE IN API FORM AND MARKETED PHARMACEUTICAL TABLET DOSAGE FORM BY USING RP-HPLC

Authors :

Miss.M.Bhavani*, MD.Yakub Pasha

Abstract :

Analytical Method Development and Validation for Dolutegravir and Lamivudine in bulk and Combine Dosage Form by RP-HPLC, New method was established for simultaneous estimation of Dolutegravir and Lamivudine by RP-HPLC method. The chromatographic conditions were successfully developed for the separation of Dolutegravir and Lamivudine by using Symmetry C18 5µm (4.6 x 150mm), flow rate was 1.0 ml/min, mobile phase ratio was Phosphate buffer (0.02M) pH-3.8: Methanol: Acetonitrile (60:20:20%v/v), detection wavelength was 260nm. The retention times of Dolutegravir and Lamivudine were found to be 2.324mins and 4.314mins respectively. The % purity of Dolutegravir and Lamivudine was found to be 99.865% and 99.658% respectively. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study n Dolutegravir and Lamivudine was found in concentration range of 0µg-36µg and 0µg-39µg and correlation coefficient (r2) was found to be 0.9995 and 0.9998, % recovery was found to be 100.280, %RSD for repeatability was 0.174 and 0.709, % RSD for intermediate precision was 0.093 and 0.937 respectively. The precision study was precise, robust, and repeatable. LOD value was 1.377 and 1.079, and LOQ value was 4.174 and 3.272 respectively. Hence the suggested RP-HPLC method can be used for routine analysis of Dolutegravir and Lamivudine in API and Pharmaceutical dosage form.
Keywords: Dolutegravir and Lamivudine, Method Development, Validation.

Cite This Article:

Determination Of Dolutigravir And Lamivudine In Api Form And Marketed Pharmaceutical Tablet Dosage Form By Using RP-HPLC., Indo Am. J. P. Sci, 2024; 11 (08).

Number of Downloads : 10

References:

1. “Principles of Instrumental Analysis”, 5th edition, Harcourt Publishes Int Company, Skoog, Holler and Nieman, Chapter 28, p.726-766.
2. “HPLC Columns” Theory, Technology and Practice. Uwe D. Neue, Wiley-VC
3. Handbook of HPLC, Vol.78, by Elena Katz et al. Marcel Dekker Inc.
4. “Instrumental Methods of Chemical Analysis”, 5th Edition, Galen W. Ewing, McGraw Hill Book Company 1988.
5. “HPLC in Pharmaceutical Industry”, Fong and Long, Marcel Dekker Series
6. “Instrumental Method of Chemical Analysis” by ChatwalAnand, Himalaya Publishing House, p.no.615-623.
7. Dr. Kealey and P.J Haines, Analytical Chemistry, 1stedition, Bios Publisher, (2002), P1-7.
8. “Practical Pharmaceutical Chemistry”, 4th edition, Part 2, by Beckett and Stenlake, CBS Publishers and Distributors, P.No.157-174.
9. Govt. of India, Ministry of Health and Family Welfare. Vol. 2. Delhi: Publication by Controller of Publication; 2007. Indian Pharmacopoeia; pp. 484–554.
10. British Pharmacopoeia.(International Ed.) 1993; Vol. 1:429, 483. Published on the Recommendation of the Medicines Commissions Pursuant to Medicines Act 1968, 1993.
11. United States Pharmacopoeia 29 NF 24, Published on the Recommendation of the Medicines Commissions Pursuant to Medicines, page no. 587.
12. Skoog, West, Holler, Crouch, “Fundamentals of analytical chemistry”, eighth edition, 2009 (Indian edition), Cengage learning India Pvt ltd, New Delhi, Page no. 271-280.
13. A.V Kasture, K.R Mahadik, S.G Wadodkar, H.N. More, “A textbook of pharmaceutical analysis, Instrumental methods”, NiraliPrakashan, vol.2, 9th edition, page no. 5-7, 28-30.
14. Settle FA, In: Handbook of Instrumental Techniques for Analytical Chemistry. 1st Ed, Singapore, Pearson Education Inc.2004.
15. Willard HH and Dean AJ. Instrumental Methods of Analysis. CBS Publishers and distributors, 7th Ed, 1986, 513-515.
16. Connors AK. In: A Text Book of Pharmaceutical Analysis. A Wiley Interscience Publication, 3rd Ed, 2005, 373-400.
17. Ahuja S. In: High Pressure Liquid Chromatography of Comprehensive Analytical Chemistry. Elsevier Publications. 2006.
18. Principles and Methods. In: Amesham Biosciences of Reversed Phase Chromatography. 6-8.
19. Synder LR, Kirkland JJ and Glajch JL. In: Practical HPLC Method Development, 2nd Ed, John Wiley and Sons Inc. Canada. 1997.
20. Mohammad T et al., HPLC Method Development and Validation for Pharmaceutical Analysis- A Review. International PharmaceuticaSciencia. 2012, 2(3), 14.
21. Snyder LR, Kirkland JJ and Glajch JL. In: Practical HPLC Method Development. 2nd ed, 2001.
22. 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.
23. Bliesner DM. In: Validating Chromatographic Methods. John Wiley & sons Inc. 2006, 88-92.
24. Validation of Analytical Procedures: Methodology. ICH-Guidelines Q2B, Geneva. 1996, 11. (CPMP/ICH/281/95).
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. ICH Topic Q 2 (R1) Validation of Analytical Procedures: Text and Methodology.
30. https://go.drugbank.com/drugs/DB08930
31. https://pubchem.ncbi.nlm.nih.gov/compound/Dolutegravir
32. https://en.wikipedia.org/wiki/Dolutegravir
33. https://go.drugbank.com/drugs/DB00709
34. https://pubchem.ncbi.nlm.nih.gov/compound/Lamivudine
35. https://en.wikipedia.org/wiki/Lamivudine
36. Dr. P. T. S. R. K. PrasadaRao, RP-HPLC Method Development and Validation for the Simultaneous Estimation of Dolutegravir and Lamivudine in Drug Product, European Journal of Biomedical AND Pharmaceutical sciences, ejbps, 2018, Volume 5, Issue 7, 538-543.
37. Sapna M Rathod, Paresh U Patel. Development and Validation of RP – HPLC Method for Estimation of Lamivudine and Dolutegravir Sodium in Synthetic Mixture, Research J. Pharm. and Tech 2020; 13(6): 2864-2868. Doi: 10.5958/0974-360X.2020.00510.7.
38. RamreddyGodela&Sowjanya G, An effective stability indicating RP-HPLC method for simultaneous estimation of Dolutegravir and Lamivudine in bulk and their tablet dosage form, Future Journal of Pharmaceutical Sciences volume 6, Article number: 9 (2020),https://doi.org/10.1186/s43094-020-00026-0.