Method stability indicating method development and validation for emtricitabina by UV spectroscopic and RP-HPLC methods

Abstract

Emtricitabine (commonly called FTC, systematic name 2 & 3’-dideoxy-5-fluoro-3-thiacytidine) is a nucleoside reverse-transcriptase inhibitor (NRTI) for the prevention and treatment of HIV infection in adults and children. The UV analysis of the drug was carried out on the 240nm wavelength. A simple, sensitive and accurate RP-HPLC method has been developed& validated for the determination of Emtricitabine in bulk formulation. Present method shows high sensitivity with linearity 10 to 50µg/ml (r2 = 0.9991). Various parameters according to ICH guidelines are followed for validating and testing of this method. Detection limit and quantitation limit were found to be 0.1534 µg ml and 0.4649 µgml respectively. The results demonstrated that the procedure is accurate, specific and reproducible and also being simple, cheap and less time consuming and appropriate for the determination of Emtricitabine in bulk formulation.