Abstract

TO ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LAMIVUDINE, ABACAVIR AND TENOFOVIR TABLETS BY RP- HPLC

*Tapare Geeta P., Jalde Swapna R., Dr. Ingole R. D.

ABSTRACT

A simple, precise, accurate, rapid, and economical RP-HPLC method was developed and validated for the simultaneous estimation of Lamivudine, Abacavir, and Tenofovir in combined tablet dosage forms used in HIV therapy. Chromatographic separation was achieved on a C18 column using an optimized mobile phase under isocratic conditions with UV detection, producing well-resolved peaks with satisfactory retention times and peak symmetry. The method was validated according to ICH guidelines for system suitability, specificity, linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD), and limit of quantification (LOQ). The calibration curves showed excellent linearity with correlation coefficients close to 1.000, while recovery and precision studies confirmed the accuracy and reproducibility of the method with acceptable %RSD values. The developed method demonstrated high sensitivity, minimal interference from excipients, and robustness under varied analytical conditions. Assay results of marketed formulations were within acceptable pharmacopeial limits, confirming the suitability of the method for routine quality control, stability studies, dissolution testing, and pharmaceutical analysis of combined antiretroviral formulations.

Keywords: RP-HPLC, Lamivudine, Abacavir, and Tenofovir.