A rapid and sensitive hptlc method for the simultaneous estimation of sofosbuvir and velpatasvir in rat plasma samples and its application to pharmacokinetic study

SUMMARY. A rapid and sensitive high-performance thin-layer chromatography (HPTLC) bioanalytical assay was developed and validated for the simultaneous estimation of sofosbuvir (SBV) and velpatasvir (VLP) in rat plasma. Simultaneous densitometry estimation of SBV and VLP as well as internal standard (IS; cabzantinib) was carried out on glass coated silica gel 60 F254 TLC plates utilizing the combination of chloroform/methanol (90:10, v/v) as the solvent system. The entire analysis was performed at 264 nm. The calibrator’s linearity was recorded in the range of 300-4000 ng/mL for SBV and VLP. The plasma samples were prepared by a simple protein precipitation method. The accuracy for SBV and VLP was obtained as 98.65-108.90 and 97.80-107.56%, respectively. The precision for SBV and VLP was recorded as 2.42-4.20 and 2.59-3.93%, respectively. The present bioanalytical HPTLC assay was applied for the evaluation of pharmacokinetic profiles of SBV and VLP in rats after single oral dose of SBV (6 mg/kg) and VLP (1.5 mg/kg). The maximum concentration in rat plasma was estimated as 1683.04 ng/mL and 560.80 ng/mL for SBV and VLP, respectively. The present HPTLC bioanalytical method could be utilized in pharmacokinetic assessment of various dosage forms having SBV and VLP.