ABSTRACT:
Emtricitabine is a nucleoside agent that has activity against both human immunodeficiency virus and hepatitis B virus. There are very few methods reported in the literature for estimation of emtricitabine using liquid chromatographic with mass spectrometer. The aim of the experiment was to develop a selective, sensitive, rugged and high throughput high performance liquid chromatography tandem mass spectrometric method for the estimation of Emtricitabine from human plasma. Emtricitabine was extracted from human plasma by solid phase extraction using Water Oasis HLB cartridges. The samples were chromatographed on Hypurity Advance, 50 x 2.1 mm, 5µ column using a mobile phase consisting of 5 mM ammonium acetate: Acetonitrile (30:70 v/v). The chromatographic separation is achieved in 1.2 minutes. The method was validated over a concentration range of 50.07 ng/mL to 5006.59 ng/mL. Method was validated for its sensitivity, selectivity, accuracy, precision, matrix effect, recovery and various stabilities. The validated method was used for analysis of plasma samples of bioequivalence study.