Development, validation, and greenness assessment of a green RP-HPLC method for rapid simultaneous estimation of brexpiprazole and escitalopram oxalate in combined dosage form

Abstract

The HPLC method has been developed and validated to achieve quantitative characterization of BRE and ESC in combination. Various performance parameters of the analytical performance, like linearity, precision, accuracy, specificity, limit of detection (LOD), and LOQ, were established based on the International Conference on Harmonization ICH Q2(R2). The isocratic technique was used to develop RP-HPLC. It is a reversed-phase C18 column measuring 250 mm X 4.6 mm and 5 microns. BRE and ESC retention times were 2.7 min and 7.0 min, respectively. The HPLC calibration gave excellent linearity (r² > 0.999) in the desired range of 0.5–3 µg/mL for Brexpiprazole and 5–30 µg/mL for Escitalopram Oxalate in the calibration curves. The procedure was demonstrated to be capable of excellent reproducibility and recovery at % RSD under 2%. Further accuracy and precision were achieved with the help of HPLC chromatographic analysis. The offered techniques are very delicate, specific, and accurate and are therefore effectively used in the establishment of the assay for brexpiprazole and escitalopram oxalate in combination.