A new stability indicating RP-HPLC method for estimation of brexpiprazole
A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Brexpiprazole in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, using a mixture of 0.1% acetic acid and methanol (65:35, v/v) as mobile phase with a flow rate of 0.9 mL/min. Detection was carried at 214nm. Linearity was observed over the concentration range of 0.1–250 μg/mL (R2 = 0.9999) with regression equation y = 39617.94x + 3300.8. 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.
Keywords: Brexpiprazole; Isocratic elution; Reversed-phase HPLC; Stability-indicating; Validation.
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