A new, simple, accurate, precise, reproducible, economical RP-HPLC method was developed for the simultaneous estimation of Lamivudine, Stavudine and Nevirapine in pure and pharmaceutical dosage form. A Phenomenex Gemini C6 Phenyl column (250mm × 4.6mm, 5µ) forms the stationary phase in isocratic mode, with the mobile phase consisting of 0.02 M Ammonium dihydrogen phosphate buffer having pH 2.5, adjusted with formic acid (98%). Buffer and methanol were used in the ratio of (50:50) to obtain well-resolved peaks of Lamivudine, Stavudine and Nevirapine from the combined dosage form. The flow rate and run time were set at 1 ml/min and 30 minutes respectively. The effluent was monitored at 264nm. The retention times for Lamivudine, Stavudine and Nevirapine were 2.837, 3.590, and 8.037 min respectively. The linearity for lamivudine, Stavudine and Nevirapine were in the range of 12-84, 24-160 and 16-112µg/ml respectively. The method was validated as per ICH guidelines Q 2B.
Cite this article:
S.K. Patro, A.K. Prusty. Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lamivudine, Stavudine and Nevirapine in Pure and Tablet form. Research Journal of Pharmacy and Technology. 2022; 15(2):541-5. doi: 10.52711/0974-360X.2022.00087
S.K. Patro, A.K. Prusty. Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lamivudine, Stavudine and Nevirapine in Pure and Tablet form. Research Journal of Pharmacy and Technology. 2022; 15(2):541-5. doi: 10.52711/0974-360X.2022.00087 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-2-7
1. Fox Z, Dragsted UB, Gerstoft J, Phillips AN, Kjaer J, Mathiesen L, Youle M, Katlama C, Hill A, Bruun JN, Clumeck N, Dellamonica P, Lundgren JD. A randomized trial to evaluate continuation versus discontinuation of lamivudine in individuals failing a lamivudine-containing regimen: the COLATE trial. Antivir Ther. 2006; 11 (6): 761-770.
2. Overington JP, Al-Lazikani B, Hopkins AL. How many drug targets are there? Nat Rev Drug Discov. 2006; 5 (12): 993-996.
3. Imming P, Sinning C, Meyer A. Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006; 5:821-834.
4. Indian Pharmacopoeia 2007, Volume II, Govt. of India, Ministry of Health and Family Welfare, Published by the Indian Pharmacopoeia Commission Ghaziabad, 5th ed., 1284.
5. Sockalingam A, Narayanareddy I, Pitchaimuthu S, and Sridhar S.K. Simultaneous quantification of Stavudine, Lamivudine and Nevirapine by UV spectroscopy, RP-HPLC and HPTLC in tablets. J of Pharmaceutical and Biomedical analysis. 2005;39 (3-4) : 801- 804.
6. Notari S, Bocedi A, Ippolito G, Narciso P, Pucillo LP, Tossini G, Donnorso RP, Gasparrini F, Ascenzi P. Simultaneous determination of 16 anti-HIV drugs in human plasma by high-performance liquid chromatography, J of Chromatography B. 2006; 831(1-2): 258–266.
7. Aymard G, Legrand M, Trichereau N, Diquet B, Determination of twelve antiretroviral agents in human plasma sample using reversed-phase high-performance liquid chromatography. J of Chromatography B. 2000; 7 (44): 227– 240.
8. Rebiere H, Mazel B, Civade C, Bonnet PA. Determination of 19 antiretroviral agents in pharmaceuticals or suspected products with two methods using high-performance liquid chromatography. J of Chromatography B. 2007; 8(50): 376 – 383.
9. Samee W, Srilamai P, Ongart S, Suwannaratana R. Simultaneous determination of Lamivudine, Stavudine and Nevirapine in the presence of their acid-induced degradation products by HPLC. Thai Pharm Health Sci J. 2007; 2 (1): 39-45.
10. Kapoor N, Khandavilli S, Panchagnula R. Simultaneous determination of Lamivudine, Stavudine and Nevirapine in antiretroviral fixed dose combinations by high performance liquid chromatography. Analytica Chimica Acta. 2006; 5 (70): 41- 45.
11. Matta MK, Rao NP, Inamadugu JK, Burugula L, Rao SJVLN. Simultaneous quantitationof Lamivudine, Zidovudine and Nevirapine in human plasma by liquid chromatography–tandem mass spectrometry and application to a pharmacokinetic study. Acta Pharmaceutica Sinica B. 2012; 2(5): 472–480.
12. Kumar DA, Babu MVN, J.V.L.N. Rao S, Rao VJ. Simultaneous Determination of Lamivudine, Zidovudine And Nevirapine In Tablet Dosage Forms By RP-HPLC Method. Rasayan. J. Chem. 2010; 3(1): 94-99.
13. Shewiyo DH. Kaale EC. Ugullum MN. Sigonda PG. Dejaegher RB, Smeyers Verbeke J Vander Heyden Y. Development and validation of a normal-phase HPTLC method for the simultaneous analysis of lamivudine, stavudine and nevirapine in fixed-dose combination tablets. Journal of Pharmaceutical and Biomedical Analysis. 2011; 54 (3), 445-450.
14. ICH. “Q2 (R1), Validation of analytical procedures: text and methodology”, in proceedings of ICH, Geneva, Switzerland. 2005; 1.11