METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

A simple, rapid, accurate and precise method was developed and validated for the simultaneous estimation of Lamivudine and Tenofovir disoproxil fumarate in pharmaceutical dosage form. The method was based on RP-HPLC. Chromatographic separation was performed on Thermosil C18 (150mm x 4.6mm, 3.5μm particle size) column using a mobile phase consisting of a mixture of KH2PO4 buffer (pH 6.0 with dilute orthophosphoric acid): Methanol: Water (33:65:2%v/v/v) in an isocratic mode. The following system conditions were maintained throughout development and validation i.e., flow rate 0.8mL/min, column was maintained at room temperature and the detected by a UV-wave length at 260nm. The Lamivudine and Tenofovir disoproxil fumarate were well resolved on the stationary phase and the retention times were 2.3 and 3.4 minutes respectively. The method was validated; both the drugs were shown to be linear over a range of 50 -150 μg/mL. The Precision, Accuracy, Specificity, Ruggedness, Robustness, LOD and LOQ were determined to validate the method.