Simultaneous Estimation of Lamivudine and Tenofovir disoproxil fumarate in Bulk and Combined Pharmaceutical Dosage Form by HPLC method

A simple, precise, selective and rapid reverse phase high-performance liquidchromatographic method was developed and validated for the simultaneousestimation of Tenofovir and Lamivudine in bulk and combined dosage form.The mobile phase used was mixture of phosphate buffer (6.5 mM) adjustedto pH 2.5 with orthophosphoric acid and acetonitrile (50:50 v/v). The InertsilC18 column (15 cm x 4.6 mm, 5 μm) was used and drugs were detected by UVdetector at 260 nm. The retention time of Lamivudine and Tenofovir werefound to be 2.04 and 3.54 min respectively. The method was linear in theconcentration range of 60-140 μg/ml and 180-420 μg/ml with correlationcoefficient (r2) of 0.998 and 0.999 for Lamivudine and Tenofovir respectively.The method was validated according to ICH guidelines with respect toaccuracy, precision, specificity and can be used to determine drug content ofmarketed formulation.