A NEW METHOD DEVELOPMENT AND VALIDATION OF AXITINIB BULK AND PHARMACEUTICAL DOSAGE FORM BY USINGUV-VISIBLE SPECTROSCOPY AS PER ICH GUIDELINES

The objective of the present work was to develop a simple, efficient and reproducible spectrophotometric method for the quantitative estimation of Axitinib drug in its active pharmaceutical ingredient (API) form. The developed UV-Visible spectrophotometric method for the quantitative estimation of drug –Axitinib measurement of absorption at a wavelength maximum (λmax) of 260 nm using methanol as diluents. The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Axitinib in pharmaceutical dosage forms.The linearity dynamic range 10-70 μg/ml and effective mean percentage recoveries were 102.5% and LOQ, LOD values of Axitinib were found to be 1.62 and 5.04(µg/ml) Key Words: Axitinib, Method Development, Validation, UV-Visible spectrophotometry.