Abstract
DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF BREXPIPRAZOLE AND FLUOXETINE IN DRUG SUBSTANCE BY RP-HPLC

B. Sowjanya* and Dr. K. Rambabu

ABSTRACT

New Analytical method was developed for the estimation of Brexpiprazole and Fluoxetine in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Inertsil ODS 3V 250*4.6mm) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Formic acid in water: Methanol(350:650). The flow rate was 0.8ml/ minute and ultra violet detector at 263nm. The average retention time for Brexpiprazole and Fluoxetine found to be 2.742 min and 3.410 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 51.5 - 154.5μg/ml for Brexpiprazole and 48.5 - 145.5μg/ml of Fluoxetine.

Keywords: Brexpiprazole and Fluoxetine, Isocratic, HPLC, Inertsil ODS 3V, Formic acid, Methanol and validation.


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