Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF PEXIDARTINIB IN PHARMACEUTICAL DOSAGE FORM

Puja Panchal*, Neha Mochi, Dr. Harsha U. Patel and Ojas Patel

ABSTRACT

A simple, rapid, economical, precise and accurate RP-HPLC method for Pexidartinib in its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Pexidartinib in its Pharmaceutical Dosage Form. The separation was achieved by C18 (250mm x 4..6 mm, 5μ) column and Buffer, pH 4.5: Acetonitrile (75:25) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 233 nm. Retention time of Pexidartinib was found to be 7.237 min. The method has been validated for linearity, accuracy and precision. Linearity observed for Pexidartinib 10-30 μg/ml. Developed method was found to be accurate, precise and rapid for estimation of Pexidartinib in its Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the estimation of Pexidartinib in Pharmaceutical dosage form.

Keywords: Pexidartinib, Stability Indicating RP-HPLC Method, Validation.