Simultaneous Estimation of Emtricitabine and Tenofovir Disoproxil Fumarate in Tablet Dosage Form by Reverse Phase High-performance Liquid Chromatography

Abstract

A simple, rapid reversed-phase high performance liquid chromatographic method had been developed and validated for estimation of Daclatasvir and Sofosbuvir in tablet dosage form. The estimation was carried out on Inertsil ODS-C 18 column (250 x 4.6 mm, 5μ) column with a mixture of Acetonitrile: Methanol: 0.1% Triethylamine buffer (pH-3.0) 25:35:40 (v/v/v) as mobile phase. UV detection was performed at 250 nm. The method was validated for linearity, accuracy, precision, specificity and sensitivity as per ICH norms. The developed and validated method was successfully used for the quantitative analysis of commercially available dosage form. The retention time was 2.09 and 3.50 min for Daclatasvir and Sofosbuvir respectively and total run time was 6.0min at a flow rate of 1.0 mL/ min. The calibration curve was linear over the concentration range of 5.0-25.0 µg/ mL for Daclatasvir and 2.0-10.0 µg/ mL for Sofosbuvir. The LOD and LOQ values were found to be 0.313 and 0.948 µg/ mL for Daclatasvir and 0.021 and 0.065 µg/mL for Sofosbuvir, respectively. The high percentage of recovery and low percentage coefficient of variance confirm the suitability of the method for the simultaneous estimation of Daclatasvir and Sofosbuvir in tablet dosage form.