QbD Approached in Method Development, Validation and Degradation Profiling of Aripiprazole a Antidepressent Agent

Abstract

The aim of present research work was to develop simple, precise and rapid RP-HPLC method for analysis of Aripiprazole in tablet dosage form using QbD Method. RP-HPLC method was developed for the estimation of Aripiprazole in tablet dosage form with the help of QbD approaches. The proposed methods were applied for the determination of drug in tablet dosage form. In this method concentration of each drug was obtained by using the absorptivity values calculated for drug wavelength 254nm and solving the equation. A rapid and reliable RP-HPLC method was developed and validated estimation of Aripiprazole in tablet dosage form. The RP-HPLC method was performed C18 (100mm x 4.6 mm,)2.5 μm particle size in gradient mode, and the sample was analyzed using methanol 80 ml and 20 ml (pH 3.3 0.05% OPA with TEA) as a mobile phase at a flow rate of 0.7 ml/min and detection at nm. By the retention time for Aripiprazole found 3.29 min respectively. The method was applied to marketed tablet formulations. The tablet assay was performed for combination was validated for accuracy, precision, linearity, specificity, and sensitivity in accordance with ICH guidelines. Validation related the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots by both HPLC were linear over the 10-50μg/ml for Aripiprazole respectively, and recoveries from tablet dosage form were between 99.48 and 100.02 %. The method can be used for routine of the quality control in pharmaceuticals. The RP-HPLC method was found to be simple, economical and rapid as compared to MS method was found to be more accurate, precise and robust. Both these methods can be used for routine analysis of Aripiprazole in tablet dosage form.