Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products

Abstract

The goal of this study was the optimization of chromatographic conditions and validation of the isocratic RP-HPLC method for monitoring the stability of aripiprazole, identification and quantitative analysis of aripiprazole and its degradation products in tablets. In addition, robustness was tested by applying the methodology of experimental design. The forced degradation study of aripiprazole was conducted in accordance with the ICH guidelines. The stability of the active pharmaceutical substance was tested under the conditions of hydrolysis in acidic, neutral and basic environments, thermal degradation, oxidation and photolysis. The active pharmaceutical ingredient was degraded under oxidation conditions, and the identity of the resulting degradation product, N-oxide, was confirmed. Under the other conditions tested, the active pharmaceutical substance was found to be stable. The developed method RP-HPLC allowed the separation of degradation products and aripiprazole and was defined as a stability-indicating method. The proposed method was validated for qualitative and quantitative analysis of aripiprazole and its degradation products. Accordingly, selectivity, linearity, precision, accuracy, limit of detection, limit of quantification, and robustness of the method were tested. The Box-Behnken experimental design was used in robustness testing.