Development and Validation of Rp-HPLC Method for the Simultaneous Estimation of Sofosbuvir, Velpatasvir and Voxilaprevir in Bulk and Tablet Dosage Forms

Abstract

A simple reverse phase analytical technique was established for quantification of single and combinational drugs. A simple, economic, accurate reverse phase isocractic RP-HPLC method was established for the simultaneous quantification of Sofosbuvir, Velpatasvir and Voxilaprevir in bulk and tablet dosage forms. The estimation was done by using Discovery C18 (250×4.6mm,5µm) column with the flow rate of 1.0 ml/min, at λmax 260 nm. Solution-A was 0.1% OPA (pH 1.8) in water and solution -B was Acetonitrile (mobile phase: solution A: solution B, 50:50 v/v). The Rt for Sofosbuvir, Velpatasvir and Voxilaprevir is 2.458 min., 3.282 min and 4.003 min. respectively. The system was established and validated as per ICH guidelines.

A Comprehensive Review on Analytical Method Development using RP-HPLC and Recent Advances in Pharmaceutical Applications

“…The mobile phase, on the other hand, is typically a mixture of an aqueous phase and an www.jrasb.com organic solvent, such as acetonitrile or methanol. The choice of the mobile phase composition depends on the sample's properties and the desired separation [18].…”

Recent advances in the chromatographic determination of the most commonly used anti‐hepatitis C drug sofosbuvir and its co‐administered drugs in human plasma

“…The most prevalent stationary‐phase columns consisted of long carbon chains (C 18 ) bound to silica, with a length of 150–250 mm and particle size 3–5 μm (Abdel‐Gawad, 2016; Hassouna & Mohamed, 2018; Miraghaei et al, 2017; Nekkala et al, 2018; Rathod et al, 2018; Sandya Rani & Devanna, 2018; Saroja et al, 2018). The use of the C 8 column was also reported for the analysis of sofosbuvir (Baker et al, 2018; Bhavsar et al, 2018; Zidan et al, 2018).…”

Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Sofosbuvir, Velpatasvir, and Voxilaprevir in Tablet Formulation

“…As per the literature survey [5][6][7][8][9][10][11], it is learned that very few HPLC methods have been reported for the determination of Sofosbuvir, Velpatavir, and Voxilaprevir individually and in combination by HPLC but there is no method for stability-indicating and simultaneous estimation of all the three drugs.…”