STABILITY INDICATING HPTLC METHOD FOR ESTIMATION  OF LOPINAVIR AND RITONAVIR IN FIXED-DOSE COMBINATION TABLETS.

Dr.G.Dharmamoorthy; S.Roopanvitha; K.Harshitha; Y.Krupananda; A.Tharunkumar5; Dr.Mallikarjuna B.P; Dr.M.Pradeep

doi:10.53555/jptcp.v30i15.2563

Dr.G.Dharmamoorthy
S.Roopanvitha
K.Harshitha
Y.Krupananda
A.Tharunkumar5
Dr.Mallikarjuna B.P
Dr.M.Pradeep

Keywords

Lopinavir(LPV) and Ritonavir(RTV), HPTLC, Forced degradation, Validation.

Abstract

A stability indicating simple, precise,accurate,rapid and validated HPTLC method for simultaneous estimation of Lopinavir and Ritanavir was successfully developed. The method is based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 266 nm.This method is based on HPTLC separation followed by UV detection at 266 nm. The separation was carried out on merck TLC aluminium sheets precoated with silica gel 60 F₂₅₄ using a camag Linomat5 The mobile consists of Benzene: ethanol : aceticacid (7:3: 0.4% v/v) . Calibration curves were linear in range of 800-4800 ng/band and 200- 1200 ng/ band Lopinavir and Ritonavir respectively . LPV and RTV gave sharp and well defined peaks at Rf value are 0.63 and 0.44 respectively, Stress degradation study shows that sample degraded with acid and base hydrolysis, under oxidation, thermal and photolytic stress conditions.. No chromatographic interferences from the tablet excipients were found. The method was validated in accordance with the requirements of ICH guidelines.

Abstract 138 | pdf Downloads 98

References

1. Hing L. Sham, David A. Betebenner , Xiaoqichen, Ayda saldirar, Sudthida Vasavanonda, Dale J. Kempf, Jacob J.Plattner and Daniel W. “Synthesis and structure activity relationship of a novel series of HIV‐1 protease inhibitors encompassing ABT‐ 378 (Lopinavir)”, Bio organic and Medicinal Chemistry Letters. 2002; 12; 8: 1185‐1187.
2. The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, Merck & Co.,Inc.,NJ; 2001.
3. Faux.J .Venisse. N, Olivier .J.Bouquet. S. “Rapid high‐ performance liquid chromatography determination of lopinavir, a novel HIV‐1 protease inhibitor, in human plasma”, Chromatographia. 2001; 54: 469‐473.
4. George Lunn, HPLC Methods for Pharmaceutical Analysis, 1996; 4: 795.
5. Budavari S, Maryadele J O’ Neil, Ann Smith, Heckelman PE. and Joanne F Kinneary, The Merck Index, 12th Ed., Monograph No. 8402, Merck, USA, 1996; 1418.
6. Corett AH, Lim LM and Kashuba AD, Ann Pharmacother. 2002; 36:1193.
7. .S. Frappier, D. Brelih, E. Diarte, B. Ba, D. Ducint; J. L. Pellegrin and M. C. Saux. “Simultaneous determination of ritonavir and saquinavir, two human immunodeficiency virus protease inhibitors, in human serum by high performance liquid chromatography”, J.Chromatogr.B. Biomed Sci Appl. 1998; 714: 384‐389.
8. Richard M. W. Hoetelmans, Marjolijn van Essenberg, Monique Profijt, Pieter L. Meenhorst, Jan W. Mulder and Jos H. Beijnen. “High performance chromatographic determination of ritonavir in saliva, cerebro spinal fluid and human plasma”, J.Chromatogr.B. Biomed Sci Appl. 1998; 705; 1: 119‐126.
9. K.V. Mangoankar, N.D. Prabhu Navelkar, A.V. Sulebhavikar and U.D.Pawar. “HPTLC method for simultaneous determination of lopinavir and ritonavir in capsule dosage form”, E‐Journal of Chemistry. 2008; 5; 4: 706‐712.
10. Carolina Lupi Dias, Ana Maria Bergold, Pedro Edurado Froehlich. “UV‐Derivative Spectrophotometric determination of Ritonavir Capsules and Comparison with LC”, Analytical Letters. 2009; 42; 12: 1900 –1910.
11. Suneetha A; Kathirvel S, Ramachandrika G,“A validated RP HPLC method for simultaneous estimation of lopinavir and ritonavir in combined dosage form”International Journal of Pharmacy and Pharmaceutical Sciences, 2011, 3(1), 49-51.
12. 13..Donato EM, Dias CL, Rossi, “LC metho for studies on the stability of lopinavir and
13. ritonavir in soft gelatin capsules”,Chromatographia , 2006, 63(9-10), 437-44
14. ICH Q2A Text on Validation of analytical procedures, International Conference on Harmonization tripartite guidelines, adapted 27 Oct 1994. HPTLC Method for Determination of Lopinavir and Ritonavir 712.
15. Sethi PD, High performance thin layer chromatography Quantitative analysis pharmaceutical formulations, 1st Edition, CBS Publishers and distributors, India, 1996
16. Touchstone JC, Practice of thin layer chromatography, 3rd Ed., Published by John wiley and sons, Inc.USA, 1992
17. Sethi PD and Charegaonkar D, Identification of drugs in pharmaceutical formulations by thin layer chromatography, 2nd Ed., CBS Publishers and distributors, USA, 1999.
18. ICH Q2B Text on validation of analytical procedures: Methodology International Conference on Harmonization Nov. 1996.
19. ICH Q2A Text on Validation of analytical procedures,International Conference on Harmonization tripartite guidelines, adapted 27 Oct 1994. HPTLC Method for Determination of Lopinavir and Ritonavir 712
20. Sethi PD, High performance thin layer chromatography Quantitative analysis pharmaceutical formulations, 1st Edition,CBS Publishers and distributors, India, 1996.
21. Touchstone JC, Practice of thin layer chromatography, 3rd Ed.,Published by John wiley and sons, Inc.USA, 1992
22. Sethi PD and Charegaonkar D, Identification of drugs in pharmaceutical formulations by thin layer chromatography, 2nd Ed., CBS Publishers and distributors, USA, 1999.
23. ICH Q2B Text on validation of analytical procedures Methodology International Conference on Harmonization Nov.1996.

pdf

Published

Aug 17, 2023

DOI https://doi.org/10.53555/jptcp.v30i15.2563

How to Cite

Dr.G.Dharmamoorthy, S.Roopanvitha, K.Harshitha, Y.Krupananda, A.Tharunkumar5, Dr.Mallikarjuna B.P, & Dr.M.Pradeep. (2023). STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF LOPINAVIR AND RITONAVIR IN FIXED-DOSE COMBINATION TABLETS. Journal of Population Therapeutics and Clinical Pharmacology, 30(15), 527–540. https://doi.org/10.53555/jptcp.v30i15.2563

Issue

Vol. 30 No. 15 (2023): JPTCP

Section

Articles

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.

Author Biographies

Dr.G.Dharmamoorthy

Professor &HOD Department of Pharmaceutical Analysis. MB School of Pharmaceutical Sciennces (Erst while Sree Vidyanikethan College of Pharmacy) Mohan Babu University.Sree Sainath Nagar.Rangampeta Tirupathi-517102 Andhrapradesh, Mobile no; +91 9603774847,