Abstract

DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR ANALYSIS OF CRISABOROLE

Amol Pimpale*, Sheetal Gondkar and Smita Aher

ABSTRACT

A simple, sensitive and accurate RP-HPLC method has been developed for the determination of Crisaborole in bulk formulation. The λmax of the Crisaborole was found to be 241nm in 10 mM Ammonium acetate buffer: ACN [60:40 % v/v]. pH 4.5. The method shows high sensitivity with linearity 5 to 25μg/ml (regression equation: y = 316606x - 427583; r2 = 0.9992). The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.1094 μg ml –1 and 0.3316 μg ml–1 respectively. The results demonstrated that the procedure is accurate, specific and reproducible (RSD <2%), and also being simple, cheap and less time consuming and appropriate for the determination of Crisaborole in bulk.

Keywords: Crisaborole, HPLC method.