Abstract
A stability-indicating RP-HPLC method was established and validated for the determination of Brexpiprazole in bulk drug using C18 column Waters (150 mm×4.6 mm, 5 µm) with a mobile phase containing of 500 mL of 10 mM monobasic Potassium phosphate buffer adjusted pH 2.0 with 85% Orthophosphoric acid and 500 mL of HPLC grade Acetonitrile. The mobile phase was filtered with a 0.45 µm membrane filter and degassed by sonicating for few minutes. The detection was performed at 213 nm using a Photodiode Array Detector at a flow rate of 1.0 mL min-1 and Brexpiprazole was eluted at 2.5 min. with column temperature 30°C. The detector response was generated from the concentration range of 0.01-0.06 mg mL-1 and regression coefficient(r) was 0.999. Brexpiprazole was exposed to stress conditions such as acidic, basic, oxidation, hydrolysis, photolysis and thermal degradation, and the outcomes showed that the molecule was more sensitive to peroxide degradation. This method was validated as per ICH and FDA guidelines and showed linearity, accuracy, precision, specificity, robustness, LOD, LOQ and system suitability results within the acceptance criteria.
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