Bioanalytical Method Development and Validation of Ranitidine from Plasma Using High Performance Liquid Chromatography (original) (raw)

Sofosbuvir (Fig. 1) is a prodrug of 2'-deoxy-2'-fluoro-2'-C-methyl-uridine monophosphate that is phosphorylated intra cellularly to the active triphosphate form, used for the treatment of chronic hepatitis C. The nucleoside triphosphate is a nonobligate chain-terminating analogue of UTP that competes for incorporation at the HCV NS5B polymerase active site. Viral RNA synthesis is inhibited secondary to incorporation of the phosphorylated metabolite into nascent viral RNA by the HCV RNA-dependent RNA polymerase [1]. Velpatasvir (Fig. 1) is both an inhibitor and a substrate of the transporter proteins P-glycoprotein (Pgp), ABCG2, OATP1B1 and OATP1B3. It is partly degraded by the liver enzymes CYP2B6, CYP2C8 and CYP3A4 [2]. Literature survey revealed that very few analytical methods were available for analysis of sofosbuvir and velpatasvir. Most of the methods were reported for analysis of sofosbuvir. Raj Kumar and Subrahmanyam [3] developed a HPLC method for the simultaneous quantification of sofosbuvir in pharmaceutical dosage form. In this reported method, mobile phase was a mixture of acetonitrile:water (75:25 % v/v). Method was developed at a wavelength of 253 nm with C18 column. The linearity range was 18.2-91 mg/mL for sofosbuvir. Zaman et al. [4] reported a simultaneous method for the determination