Rapid Determination and Validation of Sorafenib via UV-Vis Method in Pharmaceutical Formulations

Sorafenib is one of the most preffered kinase inhibitor drug that formerly approved in order to apply on therapy for primary kidney cancer (advanced renal cell carcinoma). In addition to this, this drug get allowance for the treatment of primary liver cancer (hepatocellular carcinoma), and radioactive iodine resistant advanced thyroid carcinoma. This proposed work is achieved to suggest different procedure for determination of sorafenib in pharmaceutical formulations. In order to carry out the study, reference standard samples were kindly obtained and a working concetrations were prepared in methanol ( 0.5 – 25 µg/mL) including 0.1 M HCl. All measurements were organised via UV-Vis spectrophotometer at 264 nm wavelength. Developed method was validated following ICH guideline. Precision and accuracy values for proposed method was found to be straightforwardly satisfactory whose values were better than 4% for both intra-day and inter day assays (n=6). Linearity was succesively provided between working concentration and corelation coefficien that were calculated to be 0.9966. After all succesful validation steps, method was applied to real pharmaceutical samples which kindly purchased by the local pharmaceutical store (Nevaxar). Analytical recovery study of the drug were calculated via standard addition method method. Three different quality control solutions were used to perform proposed study. To conclude, developed and validated method was succesively applied on real samples by getting satisfactory results.