Application of different analytical techniques for determination of velpatsvir and sofosbuvir in the pharmaceutical preparation

Abstract

Three analytical methods have been developed and applied for determination of velapatasvir and sofosbuvir in their new FDA-approved pharmaceutical dosage form. Capillary electrophoresis has been introduced as a powerful separation analytical technique for the simultaneous analysis of the studied drugs within a shorter analytical run time. Separation has been carried out on fused silica capillary (50 cm × 75 µm internal diameter), background electrolyte solution consisted of borate buffer (40 mM, pH 10) and UV detection carried out at 225 nm. Also, two mathematical spectrophotometric methods have been applied for resolving the recorded overlapping UV spectra of velpatasvir and sofosbuvir. Direct zero-order spectrophotometric determination of velpatasvir was done at 339 nm where no significance absorbance or contribution from sofosbuvir was observed. Savitsky–Golay filters signal processing has been achieved to enable determination of sofosbuvir in its binary mixture with velpatasvir. The amplitude of the first derivative of the sofosbuvir spectra, calculated by Savitsky–Golay filters, at 251 nm enabled the determination of sofosbuvir without any contribution of velpatasvir. The described methods have been validated and applied for determination of the studied drugs in their pharmaceutical dosage form.