Abstract

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

Manoj Bhaybhang* and Prerana Jadhav

Abstract

One spectrophotometric and several HPLC methods have been reported for determination of Brexpiprazole in drugs and in pharmaceutical dosage forms. Hence, in the present study, a new, sensitive, suitable and robust reversed-phase high performance liquid chromatography method was developed and validated for the determination of Brexpiprazole in bulk drug and in tablet formulation. In RP-HPLC method, Acetonitrile: Methanol and 10 mM phosphate buffer adjusted to a pH2.0±0.05 by diluted OPA. (45:35:20 %v/v) was used as mobile phase, at a flow rate of 1.0ml/min, on HPLC system containing UV- detector with Openlab EZchrome software and Water sperisorb C18 column (100 mm x 4.6; 5μm). The detection was carried out at 216 nm. The method gave suitable retention time i.e. 4.7 min for Brexpiprazole. The results of analysis in the method were validated in terms of Filter study, Solution stability, specificity, linearity, accuracy, precision (Repeatability and intermediate precision), limit of detection, limit of quantification and robustness. A simple and precise method was developed for the assay of Brexpiprazole in bulk drug and in tablet formulation. method need regular reagents for doing analysis and also less time consuming, it can be performed routinely in industry for routine analysis of bulk drug and marketed product of Brexpiprazole.

Keywords: RP-HPLC, Brexpiprazole, Acetonitrile, Validation.