Development and Validation of Stability Indicating Rp-Hplc Method for the Simultaneous Estimation of Sofosbuvir and DaclatasvirDihydrochloride in Bulk Drug and Pharmaceutical Dosage Form
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2018, Vol 4, Issue 5
Abstract
Abstract:A new stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Sofosbuvir and Daclatasvir in pharmaceutical dosage form and bulk drug. The optimized conditions for the simultaneous estimation of drug includes Discovery C18 (150mm x 4.6 mm, 5m) column, 0.01N potassium dihydrogen phosphate and Acetonitrile (50:50%v/v) as mobile phase run on isocratic mode at a flow rate 1.0ml/min. The column is maintained at 30ºC temperature and the drugs are detected at a wavelength of 254nm. The retention time for Sofosbuvir and for Daclatasvir were found to be 2.47 min and 3.31 min respectively. The %RSD for Sofosbuvir and Daclatasvir were found 0.8 and 0.5 respectively. The % Recovery for Sofosbuvir was found to be 99.90% - 100.03% and % recovery for Daclatasvir was found to be 99.90% - 99.93%. A linear response was found in the concentration range of 100µg/ml – 600µg/ml for Sofosbuvir and 15µg/ml – 90µg/ml for Daclatasvir, with correlation coefficient of 0.999 for both the drugs. The method was found to specific, accurate, precise, robust, rugged and stable in solution for 24 hours. The forced degradation studies indicated that the drugs are stable in various stress conditions as the net degradation was found to be within the limits. The developed method can be used for the quality control for simultaneous estimation of Sofosbuvir and Daclatasvir in pharmaceutical dosage form. Keywords:Sofosbuvir, Daclatasvir, Stability indicating, Method development, Validation, RP-HPLC.
Authors and Affiliations
Jahnavi Bandla, S Ganapaty
Keywords
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