METHOD DEVELOPMENT AND VALIDATION OF SUNITINIB IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD

Abstract

In the present work, a new validated HPLC method for quantitative determination of Sunitinib in capsule formulation was developed. The column was Phenomenex Luna C18 column (150 mm × 4.6 mm id; 5μm particle size) and the mobile phase was composed of Acetonitrile: Methanol: Water (70:20:10, v/v/v) with a flow rate 1 ml/min. Eluents were monitored by UV detector at 277 nm. Calibration curve was linear in the concentration range 3 – 15 μg/ml (R2 value is 0.9993). The proposed method was successfully applied for the assay of Sunitinib in capsule formulation and validated as per ICH guidelines.