Original Articles
Sk Mastanamma, D Venkata Reddy
Abstract
The present work describes development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Emtricitabine tenofovir alafenamide bulk and their combined dosage form. The chromatographic separation was performed on Column: Inertsil ODS (4.6 × 250 mm, 5 ïÂÂÂÂÂÂm) using phosphate buffer: Acetonitrile (80:20) as mobile phase at a flow rate of 1 mL/min and column oven temperature of 30ºC. The detection was carried out using a Diode array detector at 259 nm. The linearity of the method was determined in concentration range of 20-100 μg/ml for Emtricitabine, 0.25-12.5 μg/ml for Tenofovir alafenamide. The retention times of EMT and TAF were found to be 3.314 and 5.068 respectively. Average correlation coefficient R2=0.999 for all the drugs with %RSD values ≤2.0 across the concentration ranges studied, was obtained from regression analysis. Recovery studies was found to be 98.86% for Emtricitabine and 99.96% Tenofovir alafenamide with the value of RSD less than 1% indicating that the proposed method is accurate for the simultaneous estimation of all drugs from their combination drug products in presence of their degradation products. The LOD that were found to be 0.1μg/ml for Emtricitabine and 0.0125 μg/ml for Tenofovir alafenamide drug. The LOQ for Emtricitabine and Tenofovir alafenamide were found to be 0.3 μg/ml and 0.0375μg/ml respectively. Total run time was 10 minutes within which main compounds and their degradation products were separated. The developed method was successfully applied to the simultaneous quantitative analysis of the title drugs in tablet dosage forms.