Abstract

METHOD DEVELOPMENT AND VALIDAITON OF PEXIDARTINIB USING RP-HPLC

M. Vijaya Kumari* and Ch. Balasekhar Reddy

ABSTRACT

A simple, sensitive and rapid chromatographic method was developed and validated for the quantification of Pexidartinib using reverse phase HPLC. The chromatographic Separation was performed on a column X-Bridge C8 (150mmx4.6mm, 3.5 μ) with acetonitrile and 0.1% formic acid (70:30 v/v) as a mobile phase and flow rate was kept at 1 ml/min. Good sensitivity was found with UV detection at 225 nm. After method development the method was validated according to ICH guidelines. Chromatography was administered isocratically at ambient temperature and 5 min run time was maintained, then the retention time of Pexidartinib was found to be 2.271 min. The method was validated over the analytical linearity range from 4-60 μg/ml with r2 value 0.999. This method showed good reproducibility and recovery with % RSD in the desired range. The Limit of detection and Limit of quantification was found to be 0.04ug/ml and 0.4ug/ml. The proposed method can be successfully applied for the routine analysis of Pexidartinib in pharmaceutical dosage form.

Keywords: Development, validation, pexidartinib, HPLC.