Research Article
Sreekanth Nadig and Jane T Jac
Abstract
A simple, faster reverse phase UPLC method has been developed for quantitative estimation of Emtricitabine impurities in pharmaceutical dosage form. Emtricitabine is an antiretroviral compound that inhibits the HIV-1 reverse transcriptase. Chromatographic separation was achieved on Waters Acquity UPLC BEH C8 , 100x 2.1 mm ,1.7μm column in a gradient mode elution. Detection wavelength was set at 270 nm. Drug product was subjected for stress conditions of Acid, Alkali and Peroxide degradation. Emtricitabine was found to have degraded significantly in peroxide condition. Peak purity results of Emtricitabine indicated that all degradents are separated from the analyte peak. The developed method was validated as per ICH guidelines with respect to Specificity, Linearity, Accuracy, Precision, Limit of detection and quantification.