VALIDATED METHOD DEVELOPMENT FOR THE ASSAY OF BREXPIPRAZOLE IN PHARMACEUTICAL FORMULATIONS

Analytical method was developed for the estimation of Brexpiprazole drug substance by liquid chromatography. The chromatographic separation was achieved on Inertsil ODS C8 150*4.6, 3um at ambient temperature. The separation achieved employing a mobile phase consisting of 0.1%v/v Trifluoro acetic acid in water: Acetonitrile (30:70). The flow rate was 0.7 ml/ minute and ultra violet detector at 315nm. The average retention time for Brexpiprazole was found to be 2.16 min. The proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 50-150µg/ml for Brexpiprazole.