METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF SUNITINIB MALATE IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS

Madireddy Mamata*

ABSTRACT

A simple, rapid, specific and accurate reverse phase high performance liquid chromatographic method has been developed for the validated of Sunitinib malate in bulk as well as in marketed pharmaceutical dosage form. This separation was performed on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5μm column with Methanol and DMSO in the ratio of 60:40 as mobile phase at a flow rate of 1.0 mL min−1 with UV detection at 430nm; the constant column temperature was Ambient. The run time under these chromatographic conditions was less than 6.0 min. The retention time of Sunitinib was found to be 2.570min. The calibration plot was linear over the concentration range of 6–14 μg mL−1 with limits of detection and quantification values of 0.8 and 0.24ng mL−1 respectively. The mean % assay of marketed formulation was found to be 99.79%, and % recovery was observed in the range of 98-102%. Relative standard deviation for the precision study was found <2%.The developed method is simple, precise, specific, accurate and rapid, making it suitable for estimation of Sunitinib in bulk and marketed pharmaceutical dosage form dosage form.

Keywords: Sunitinib, RP-HPLC, Validation, Accuracy, Precision, Robustness, ICH Guidelines.