Development of stability indicating, validated HPLC method for quantitative determination of Aripiprazole and its impurities

By Nandini R. Pai and Deepnandan S. Dubhashi


The present paper describes the development of a simple, rapid and stability indicating reversed phase column liquid chromatographic method for 7-[4-{4-(2,3-dichlorophenyl) piperazine-1-yl}butoxy]-3,4-dihydro-1H-quinolin-2-one, a leading antipsychotic drug known by the generic name Aripiprazole in the presence of its impurities and degradation products generated from forced decomposition studies. Successful separation of the drug from the synthetic impurities and degradation products formed under stress conditions is achieved on Zorbax C18 ( 150 x 4.6x 5 micron) using a gradient elution  of 0.2% trifluoroacetic acid in water and 0.2% trifluoroacetic acid in Methanol. The developed LC method is validated as per ICH guideline for validation parameters like specificity, precision, linearity, accuracy, limit of detection and limit of quantitation. Linearity of the impurities is established and correlation coefficient is found to be above 0.995 for every impurities. Recoveries of impurities are found between 100.87% and 103.68%. The proposed validated, stability indicating liquid chromatographic method for the related substances determination can be used to evaluate quality of Aripiprazole drug samples from regular production batches. It can also be utilized for testing the stability samples of Aripiprazole drug which will be of great help to quality control chemist and thus have robust industrial application.

Key words: Antipsychotic, Stability indicating method, ICH guideline, Validation.

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