Rathod, Rahul U and Navyasree, KS and Bhat, Krishnamurthy (2018) Quantification of sofosbuvir in human plasma: Rp-hplc method development and validation. Pharmaceutical Chemistry Journal, 52 (7). pp. 663-673. ISSN 0091-150X

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Abstract

Sofosbuvir, a potential inhibitor of the nucleotide analog of hepatitis C virus (HCV) NS5B polymerase, is used to treat hepatitis C and marketed under brand name Sovaldi. This study was aimed to develop and validate a simple, sensitive and precise RP-HPLC method for the estimation of sofosbuvir in human blood plasma using quinine sulfate as internal standard (ISTD). Separation was achieved using Shimadzu-HPLC system equipped with Gracesmart RP-C 18 (250 mm � 4.6 mm, 5 �m) column eluted at a flow rate of 0.5 mL/min and detected at 260 nm. The mobile-phase composition was optimized to be ammonium formate (pH 3.0; 10 mM) and acetonitrile (67 : 33, % v/v). The retention times of sofosbuvir and quinine sulfate were found to be 13.60 and 8.39 min, respectively. The proposed method was linear over a range from 20 to 1200 ng/mL. Liquid–liquid extraction technique was applied for the extraction of drug and ISTD from human plasma using TBME – DCM (80 : 20, % v/v) mixture. The proposed method was validated as per bioanalytical method validation guidelines for industry.

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