Method Development and Validation for Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Pure and Tablet Dosage Form by using RP-HPLC

A simple, precise, accurate and rapid RP-HPLC method with PDA detector has been developed and subsequently validated for the simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in pure and tablet dosage form. The estimation was carried out on a Phenomenax Luna C18 (250mm x 4.6mm i.d; particle size 5µm) column with mixture of methanol: phosphate buffer pH-3 (70:30 v/v) as mobile phase. The flow rate was 1ml/min. UV detection was performed at 258 nm. The method was validated for linearity, accuracy, precision, robustness, LOD, LOQ as per ICH guidelines. The developed and validated method was successfully used for the quantitative analysis of commercial available dosage form. The retention time was 2.605 min and 3.781 min for emtricitabine and tenofovir disoproxil fumarate, respectively. The calibration curve was linear over concentration range of 45105µg/ml for tenofovir disoproxil fumarate and 30-70µg/ml for emtricitabine. The correlation coefficient (r2) was found to be 0.999.Amount of emtricitabine and tenofovir disoproxil fumarate was found to be 199.4mg/tab and 298.6mg/tab respectively. The %RSD values were less than 2 for method precision. LOD and LOQ were found to be limits for emtricitabine and tenofovir disoproxil fumarate. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of emtricitabine and tenofovir disoproxil fumarate in pure and tablet dosage form.