Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CERITINIB IN PHARMACEUTICAL FORMULATION BY RP-HPLC

Arun Kumar Kuna*, S. Ganapaty and G. V. Radha

Abstract

A simple, specific and accurate reverse phase high performance liquid chromatographic method was developed for the determination of Ceritinib in pharmaceutical dosage form. The column used was Kromosil C18, 250 x 4.6 mm, 5, with mobile phase containing Buffer and Acetonitrile were taken in the ratio of 40:60 the flow rate was 1.0 mL/ min and eluent was monitored at 320nm. The retention time of Ceritinib was 2.337 min. The linearity of the drug was designed at a range for which correlation coefficient was 0.9992. The proposed method was validated and successfully applied to the estimation of Ceritinib in formulations. Forced degradation studies are conducted to identify reactions which may occur to degrade a processed product.

Keywords: Ceritinib, RP-HPLC, Validation, Degradation.