Development and validation of stability indicating RP-HPLC method for estimation of Brexpiprazole from bulk and tablet form
A sensitive, selective, rapid, precise, and economic stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method were developed for the quantification of Brexpiprazole in bulk and pharmaceutical dosage form was performed on Shimadzu Model HPLC 3000 series, using a mixture methanol and water (90:10, v/v) with OPA as mobile phase with a flow rate of 0.9 mL/min. Detection was carried at 215nm. The retention time of Brexpiprazole was 5.099min. Linearity was observed over the concentration range of 10–50 μg/mL (R2 = 0.9989) with regression equation y = 71185x-482587.The Accuracy study was performed % recovery of Brexpiprazole. The % recovery was found to be 50%=100.13%,100%=99.58%,150%=99.84%.(NLT 98% and NMT 102%). The Relative standard deviation values for intraday precision and intraday precision were found to be less than 2% i.e. 0.25% and 0.40% respectively. 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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