Abstract
Four chemometric assisted spectrophotometric models were developed for the quantitative analysis of velpatasvir and sofosbuvir, in their newly FDA approved pharmaceutical dosage form. Due to the existed overlap of the scanned absorption spectra between velpatasvir and sofosbuvir, this resulted in degree of difficulty of the possibility of the conventional spectrophotometric methods to quantify and analyze the cited drugs simultaneously. Classical least squares, principal component regression, partial least squares and genetic algorithm partial least squares were designed and compared for the quantitative analysis of velpatasvir and sofosbuvir in their binary mixture. Experimental design for different concentrations of the studied drugs was done based on the spectral sensitivity of velpatasvir and sofosbuvir and the confirmed ratio of the two drugs in the commercial pharmaceutical dosage form. Optimization of the described models was adopted with the aid of five-levels, two factors experimental design. Successfully quantitative assay of the drugs in Epclusa® tablets was done by the proposed models. Statistically comparative analysis for the obtained models results with another published capillary electrophoresis quantitative analytical method was performed. It is noteworthy mentioning that there was no significant difference between the proposed models and the published method with respect to the accepted statistical parameters.
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