Friday , 21 January 2022

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

K.Nithiyananthan1*, K.V.S.Prasadarao2
1Research Scholar, Acharya Nagarjuna University, Guntur, Andhra Pradesh 522510.
2Principal, Rahul Institute of Pharmaceutical Sciences and Research, Chirala, Andhra Pradesh 523157.

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.

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