STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF BREXPIPRAZOLE IN BULK DRUG AND DOSAGE FORM

Abstract

A sensitive, selective, rapid, convenient, and economic stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method were developed for the Validation and development for the Estimation of Brexpiprazole in bulk and pharmaceutical dosage form was performed on EZ- Chrome Software, Column: Kromasil C18,Column Dimension: (250 mm X 4.6 mm i.d.) 5μm ,Column Oven temperature: 40°C .using Methanol : 0.1%TFA (40:60%, v/v) as mobile phase with a flow rate of 1ml/min. Detection was carried at 216nm. Linearity was observed over the concentration range of 80-120 μg / ml .(R2=0.99983) with regression equation Y=mx=c,Y=1179203.12x+7782378.40. From the Accuracy study was performed % recovery of Brexpiprazole. The % recovery was found to be 80%=100.16, 100%=99.91%, 120%=98.86%. The overall recovery is 99.64% while %RSD for overall recovery is found to be 0.842. The relative standard deviation values for interday and intraday precision was found to be less than 2% i.e. 0.434 and 0.549 respectively. The LOD AND LOQ values were found to be LOD = 0.96 µg/ml, LOQ=2.91 µg/ml respectively. Brexpiprazole was subjected to stress conditions (acidic, alkaline, oxidation and thermal degradation) and validated as per ICH guidelines. The validated method can be applied to perform long-term and accelerated stability studies of Brexpiprazole formulations.