Development and Validation of Rp Hplc Method for the Simultaneous Estimation of Tenofovir Disproxil Fumerate and Lamiudine in Combined Dosage Form

A highly sensitive isocratic reverse phase high performance liquid chromatographic method was developed and validated for the estimation of Tenofovir disproxil fumerate and Lamivudine in Bulk drug and Pharmaceutical dosage forms. Separation of Lamivudine and Tenofovir successfully achieved on symmetry C18 (4.6 x 150mm, 5m, Make: Thermosil) or equivalent utilizing HPLC Methanol and Water in the ratio of 70:30 v/v as mobile phase at a flow rate of 1mL/min and the eluates was monitored at 270 nm. Chromatogram showed peak at a retention time of 2.318 ± 1 min and 3.535 ± 1 min. The method was validated for system suitability, linearity, precision, accuracy, specificity, ruggedness, robustness, LOD and LOQ. Recovery of Tenofovir disproxil fumerate and Lamivudine were found to be in the range of 100.4% and 100.5% and showing linearity in the range of 20-60 μg / ml. The S/N for LOD and LOQ for estimation of Tenofovir disproxil fumerate and Lamivudine were found to be 3.04 μg / ml and 9.94μg/ml and 2.97μg/ml and 9.98μg/ml respectively. Proposed method can be successfully applied for the quantitative determination of Tenofovir disproxil fumerate and Lamivudine in Bulk drug and Pharmaceutical dosage form.