P. Priyanka, Ramesh Dhani*, M. Suchitra
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Nellore.
A simple, precise, accurate rp-hplc method has been developed and validated for the sofosbuvir and velpatasvir in bulk and pharmaceutical dosage form. This method was carried out by using Inertsil ODS-3(4.6 x 150mm, 5mm). Mobile phase containing phosphate buffer (ph4.8): Acetonitrile (35:65) at a flow rate 0.6ml/min. Optimized wavelength 244nm. Retention time of sofosbuvir and velpatasvir were found to be 2.22 min and 5.80 min. The precision study was precise, robust, repetable.LOD and LOQ were both drugs found to be 3.0, 10.02 and 3.00, 10.07 respectively. The %RSD values were found to be <2. A Forced degradation study of sofosbuvir and velpatasvir under the condition of hydrolysis, thermal, oxidative, photolysis. The developed method is validated in accordance with ich guideline. The result of the study showed that the proposed method is simple, rapid, and accurate.
Keywords: Sofosbuvir, Velpatasvir, RP-HPLC, Validation