Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF NILOTINIB IN BULK AND TABLET DOSAGES FORM

*Aakanksha Rade, Khushabu Patil, Tejaswini Thorat, Pragati Patil and Dipti Shinde

Abstract

A simple and reproducible method was developed for nilotinib by Reverse Phase High Performance Liquid Chromatography (RPHPLC). nilotinib was separated on C 18 column [4.6x250mm, particle size 5μm] at the UV detection of 250nm. Methanol, Acetonitrile, Water (0.1%) was used as a mobile phase with various ratios and flow rates, eventually 30:20:50 v/v Methanol, Acetonitrile, Water (0.1%) was being set with the flow rate of 1.0mL/min. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, further the limit of detection and limit of quantification of nilotinib concentrations were found to be within the limits. Recovery and assay studies of nilotinib were within 99 to 102% indicating that the proposed method can be adoptable for quality control analysis of nilotinib.

Keywords: Nilotinib, HPLC, Wavelength, Linearity, Assay.