Development of Green RP-HPLC method for determination of sorafenib in film-coated tablets

A new green RP-HPLC method for the determination of sorafenib in film-coated tablets was developed and validated. The chromatographic separation was carried on a LichroCART® 60 RP-select B column, using isocratic elution mode, with a mobile phase consisting of a mixture of phosphate buffer, pH 6.0 and ethanol (45:55% V/V), maintaining the column temperature at 30 ºC. The detection wavelength was set at 265 nm. The method was validated according to the ICH guideline, with the focus on specificity, linearity, sensitivity, accuracy, precision, and robustness. The results for the greenness assessment, obtained with the Analytical Method Greenness Score (AMGS) calculator and the Analytical Greenness Metric (AGREE) software, showed that the proposed method has lower negative environment impact compared with the reference method. The method can be used in quality control of sorafenib film-coated tablets in the pharmaceutical industry, as well as in the authorized quality control laboratories, providing mitigation of the environmental pollution.