Abstract

A simple, specific and accurate RP-HPLC method was developed for the determination of Sunitinib malate in bulk and its pharmaceutical dosage form. Hypersil ODS C18 (4.6 x 150mm, 5 m,) column was used in isocratic mode with mobile phase containing Acetonitrile : phosphate buffer pH 3.0 (pH adjusted with orthophosphoric acid) in the ratio of 50:50 v/v. The flow rate was 1.0 mL/ min and eluents was monitored at 248nm. The retention time Sunitinib malate was found to be 2.567 min, respectively. The linearity for Sunitinib malate was in the range of 10-50 μg/ml respectively. The mean recovery of Sunitinib malate was found to be 99.5%, respectively. The proposed method was validated according to ICH guidelines and successfully applied to the estimation of Sunitinib malate in capsule dosage form. The developed method was very simple, economic, accurate and precise and can be used for routine quality control examination of capsules of Sunitinib malate.