Resolving a Binary Mixture of Hepatoprotective Drugs Using Different Validated Spectrophotometric Methods

Abstract

This work is concerned with development and validation of two simple, specific, accurate and precise spectrophotometric methods for determination of two hepatoprotective drugs, silymarin (SR) and vitamin E acetate (VE), in their binary mixtures and a pharmaceutical formulation. Method A is a ratio difference spectrophotometric method (RDSM), while method B is a mean centering of ratio spectra spectrophotometric one (MCR). In both methods, the absorption spectra of each drug were recorded, divided by a suitable divisor, then the obtained ratio spectra were subtracted at two specific wavelengths in the ratio difference spectrophotometric method, while the obtained ratio spectra were mean centered in the mean centering of ratio spectra spectrophotometric method. The specificity of the developed methods was assessed by analyzing different laboratory prepared mixtures containing SR and VE. The two methods were validated as per the International Conference on Harmonization guidelines. Accuracy, precision and repeatability were found to be within the acceptable limits.