Development and Validation of Analytical Method for Quantification of Emtricitabine, Tenofovir and Efavirenz in Drug Substances and in Tablet Dosage Form by High Performance Liquid Chromatography

A simple, rapid, accurate, robust and reproducible RP HPLC method has been developed and validated for the analysis of FTC, TFV and EFV in drug substances. The chromatographic quantification was carried out using Inertial ODS-3V column C18 (250 × 4.6 mm, 5 µm) with MP composition of ACN: 1%IPA in 80:20%v/v at flow rate 1 mL/min and temperature of 30°C. UV Spectrophotometric detection was employed at 256 nm, the Rt was found to be 2.4, 2.8 and 5.2 min. The detector response was linear in the range of 5-25, 7.5-37.5 and 15-45 µg/ml respectively. The LOD and LOQ of were found to be 0.065 tom 0.198 µg/ml respectively. The precision values, expressed as % RSD values were 0.30, 0.52 and 0.23. The tablet % assay of FTC, TFV AND EVF was found 101.83, 98.26 and 100.17%. The accuracy was in the range of 100.4 to 100.6%. The method was successfully employed for the quantification of FTC, TFV and EFV in quality control of pharmaceuticals.