Articles Accepted

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF SOFOSBUVIR AND DACLATASVIR IN TABLET DOSAGE FORMS
by Ms. Monika, 21 Jun 2021

New Stability indicating RP-HPLC method for the simultaneous estimation of Sofosbuvir and Daclatasvir in its pharmaceutical dosage form was developed and developed method was validated. Column use for that was Phenomenex C18 (150mm x 4.6mm, 5µ) column using mobile phase on water and acetonitrile (50:50%v/v) in isocratic mode. Flow rate of mobile phase 1.0 ml/min and column oven temperature is maintained at 30ºC. The sofosbuvir and daclatasvir were detected at a wavelength 230 nm. The retention time for Sofosbuvir and Daclatasvir were found to be 3.06 min and 4.76 min respectively. Validation of the method was done according to ICH guidelines. The method was found to be accurate, precise, specific and robust. The method shows good Linearity in concentration range of 50 µg/ml – 500 µg/ml of Sofosbuvir and 7.5 µg/ml – 75 µg/ml of Daclatasvir, with correlation coefficient of 0.999 for both the drugs. The drugs as well as their degradation products produce in stress study were separated using this developed method.

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