Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF BREXPIPRAZOLE IN TABLET

Chandrakant C. Jaiswal* and Prof. Harsha U. Patel

ABSTRACT

A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for Brexpiprazole in its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Brexpiprazole in its Pharmaceutical Dosage Form has been developed. The separation was achieved by Cosmosil (250mm x 4.6 mm) column and Buffer (pH 4.0): Methanol (40:60) as mobile phase, at a flow rate of 1 mL/minute Detection was carried out at 248 nm. Retention time of Brexpiprazole was found to be 4.307 minutes. The method has been validated for linearity, accuracy and precision. Linearity observed for Brexpiprazole 10-30 μg/ml. Developed method was found to be accurate, precise and rapid for estimation of Brexpiprazole in its Dosage Form. The drug was subjected to stress condition of ydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in Thermal degradation. The proposed method was successfully applied for the estimation of the drug in commercial dosage form.

Keywords: Brexpiprazole, Stability indicating RP-HPLC Method, Validation.