Abstract

A NOVEL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF NILOTINIB IN BULK AND MARKETED PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Santanu Kumar Hotta* and Biswanath Prusty

ABSTRACT

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Nilotinib in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5μm) column using a mixture of Methanol and water (45:55% v/v) as the mobile phase at a flow rate of 0.8ml/min, the detection was carried out at 260nm. The retention time of the Nilotinibwas 2.379±0.02min respectively. The method produces linear responses in the concentration range of 24-120mg/ml of Nilotinib. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. The method was validated for accuracy, precision, linearity, robustness, ruggedness and LOD & LOQ of standard
solution. The developed RP-HPLC method was found to be accurate, precise, linear, and robust and was successfully applied to a pharmaceutical tablet formulation for qualitative estimation of Nilotinib in Bulk form and Marketed Pharmaceutical Dosage forms.

Keywords: Nilotinib, RP-HPLC, Method Development, Validation, Accuracy, Precision.