Abstract
A rapid and sensitive novel reversed phase-HPLC method with UV detection at 254 nm was developed for analysis of sorafenib in pharmaceutical formulations and bulk drugs. The column used was a Symmetry (R) C18, 5 mu m, 3.9 x 150 mm) for the chromatographic analysis by isocratic elution of mobile phase comprising a combination of acetonitrile and phosphate buffer (65:35, % v/v) with flow rate at 1.2 mL/min at pH 4. The method was developed and validated for linearity, accuracy, precision, sensitivity, system suitability, selectivity, and robustness. A statistical design (3(2)-factorial), central composite rotatable experimental design was employed for the validation of robustness using three factors such as mobile phase composition, flow rate and pH using retention time as response. The design exhibited those changes in the composition of mobile phase and rate of flow affects the responses produced, while pH has no substantial effect on the responses. The proposed experimental design was validated by ANOVA and showed that the proposed method was sensitive, simple, and robust for routine analysis of sorafenib in formulations.