Analytical Method Development and Vaidation for Velpatasvir and Sofosbuvir in combined Dosage Form by RP-HPLC

K.Nithiyananthan^1*, K.V.S.Prasadarao^2
1Research Scholar, Acharya Nagarjuna University, Guntur, Andhra Pradesh 522510.
²Principal, Rahul Institute of Pharmaceutical Sciences and Research, Chirala, Andhra Pradesh 523157.

A B S T R A C T
The estimation of Velpatasvir and Sofosbuvir was done by RP-HPLC. The Phosphate buffer was pH 3.0 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of 70:30 % v/ v. Inertsil C18 column  C₁₈ (4.6 x 150mm, 5µm) or equivalent chemically bonded to porous silica particles was used as a stationary phase. The detection was carried out using a UV detector at 225nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of Velpatasvir and Sofosbuvir were found to be from 100-500 µg/ml of Velpatasvir and 1-5µg/ml of Sofosbuvir. The linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating the accuracy and precision of the method. The percentage recovery varies from 98-102% of Velpatasvir and Sofosbuvir. LOD and LOQ were found to be within the limit. The results obtained on the validation parameters met ICH and USP requirements.
Keywords: Velpatasvir and Sofosbuvir, Phosphate buffer, Inertsil C₁₈ column.