Journal article Open Access

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF BREXPIPRAZOLE IN DRUG SUBSTANCE BY RP-HPLC METHOD

A.Sravani, CH.Naga Durga, Uppalapati Divya, CH.Suneetha, P.Suresh, Dr B Tirumaleswara Rao, Dr. Challa Sudheer*

Analytical method was developed for the estimation of Brexpiprazole drug substance by liquid chromatography. The chromatographic separation was achieved on C18 column (Inertsil ODS 3V 150*4.6, 5um) at ambient temperature .the separation achieved employing a mobile phase consists of 0.1%v/v Formic acid in water: Methanol (35:65). The flow rate was 0.8 ml/ minute and ultra violet detector at 315nm. The average retention time for Brexpiprazole found to be 2.27 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.

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