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Development and validation of stability indicating RP-HPLC method for the estimation of Daclatasvir in bulk and formulation | Abstract
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Abstract

Development and validation of stability indicating RP-HPLC method for the estimation of Daclatasvir in bulk and formulation

Author(s): K. Sumathi, K. Thamizhvanan and S. Vijayraj

A Novel simple, precise and economical reverse phase high performance liquid chromatographic method has been developed and validated for the estimation of Daclatasvir in single dosage form HPLC – WATERS Model NO.2690 series Compact System Consisting of Inertsil-C18 ODS column with a mobile phase constituting of Acetonitrile and Methanol (70:30) Flow rate 1ml/min and detection was carried out at 230nm. The selected chromatographic conditions were found to effectively separate Daclatasvir (Rt: 2.658 min). The developed method was validated for linearity, accuracy, precision, LOD, LOQ, robustness, ruggedness and for system suitability parameters as per ICH guidelines. Linearity for Daclatasvir was found in the range of 20-80μg/ml, respectively. The method was found to be robust. The proposed method could be used for routine analysis of Daclatasvir in single dosage forms. The bulk drug was subjected to forced degradation studies like acid, alkali, oxidative, thermal conditions.