STABILITY INDICATING HPLC METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF DACLATASVIR IN PURE AND TABLETS DOSAGE FORMS

A sensitive, simple, selective and accurate HPLC method was developed and validated for analysis of antiviral drug Daclatasvir (BMS-790052, DCV) in pure form and in tablet dosage form in the presence of its degradation products. The chromatographic separation achieved by isocratic elution on Hypersil BDS C18, 4.6×150 mm, 5?m column at 25˚c. The mobile phase was a mixture of 0.05M Potassium dihydrogen phosphate (pH-4.5) and acetonitrile in ratio of 50:50 (v/v). The injection volume was 10?l. The flow rate was 1ml/ minute. The detection wavelength was 320 nm. The developed method was validated as per ICH guidelines; it was precise, accurate and robust. The calibration curve of Daclatasvir was linear in range 0.5- 100?g/ml with a correlation coefficient ? 0.999. Also the validated method was helpful for rapid routine analysis as the run time was less than 3 minute; the retention time for Daclatasvir was about 2.33 minute. The method was successfully applied to analysis of Daclatasvir in tablet form and the recovery was from 99.71% to 100.86%. Keywords: HPLC, stability indicating, Daclatasvir, tablets.