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Quantitative Estimation of Daclatasvir In Drug Substances and Formulated Drug Product By UPLC | Abstract
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Abstract

Quantitative Estimation of Daclatasvir In Drug Substances and Formulated Drug Product By UPLC

Author(s): Sreekanth Nadig and Jane T Jacob

A simple, faster reverse phase UPLC method has been developed for quantitative estimation of Daclatasvir in pharmaceutical dosage form . Daclatasvir is one of recently developed drug for the tretatement of Hepatitis C virus.Daclstavir is a NS5A inhibitor developed by Bristol-Myers squibb. Chromatographic separation was achieved on Kinetex C18, 50x 4.6 mm ,2.6μm column. Detection wavelength was set at 318 nm. Drug product was subjected for stress conditions of Acid, Alkali ,Peroxide and Thermal degradation. Daclatasvir was found to have degraded significantly in alakline condition. Peak purity results of Daclatasvir 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 and Robustness.