Development and validation of RP-HPLC method for estimation of brexpiprazole in its bulk and tablet dosage form using Quality by Design approach

Abstract Background A new, sensitive, suitable, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the determination of brexpiprazole in bulk drug tablet formulation was developed validated this research. Surface methodology used to optimize data, with a three-level Box-Behnken design. Methanol concentration mobile phase, flow rate, pH were chosen as three variables. The separation performed using an HPLC UV detector Openlab EZchrom program, well Water spherisorb C 18 column (100 mm × 4.6; 5m). Acetonitrile pumped at rate 1.0 mL/min 10 mM phosphate buffer balanced 2.50.05 by diluted OPA (65:35% v/v) detected 216 nm. Result RP-HPLC yielded suitable retention time 4.22 min, which optimized Design Expert-12 software. linearity established verified correlation coefficient (r 2 ) 0.999 over range 5.05–75.75 g/mL. For API formulation, percent assay 99.46% 100.91%, respectively. percentage RSD method’s precision found be less than 2.0%. recoveries discovered between 99.38 101.07%. 0.64 μg/mL 1.95 LOD LOQ, Conclusion system takes can industry routine quality control/analysis marketed products. Graphical abstract