Development and Validation of RP-HPLC for Estimation of Brexpiprazole in Bulk Drugs

Abstract

A simple, rapid, accurate, and sensitive method was developed for quantitative analysis of Brexpiprazole in bulk dosage form using reverse phase high-performance liquid chromatography with UV detection. The chromatography separation was achieved on Kromasil -C18, (250 mm × 4.6 mm i.d., 5 μm particle size), at column temperature 25°C ± 2, in the isocratic mobile phase mode using acetonitrile 5% ortho-phosphoric acid: water (60:40 v/v) at a flow rate of 1.0 mL/min. The determination was performed using waters HPLC with UV detector set at 216 nm. Samples were prepared with diluent methanol, and the volume injected was 20 μL. The retention time for brexpiprazole was 3.89 min. The analytical curve was linear (r2=0.99994) over a wide concentration range (0.51–7.50 μg/mL). The presence of components of the bulk did not interfere in the results of the analysis. The method showed adequate precision with a relative standard deviation <2%.