A Validated specific Stability-indicating RP-HPLC method for Aripiprazole and its related substances


ABSTRACT :

A validated specific stability indicating reversed-phase liquid chromatographic method was developed for the quantitative determination of Aripiprazole and its related substances in bulk samples, pharmaceutical dosage forms in presence of degradation products. Forced degradation studies were performed on bulk sample of Aripiprazole as per ICH prescribed stress conditions using acid, base, oxidative, thermal stress and photolytic degradation to show the stability indicating power of the method. Significant degradation was observed during basic stress and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked with Aripiprazole. Good resolution between the peaks corresponds to impuritiy-1, degradation products from the analyte were achieved on YMC PACK C18 column using the mobile phase consists a mixture of Sodium dihydrogen Orthophosphate dehydrate with1-Hexane sulfonic acid sodium pH adjusted to 3.0 with ortho-phosphoric acid in water and Acetonitrile using a simple linear gradient. 



The detection was carried out at 215 nm.The stressed test solutions were assayed against the qualified working standard of Aripiprazole and the mass balance in each case was in between to 98.9-100.1% indicating that the developed LC method was stability-indicating. Validation of the developed LC method was carried out as per ICH requirements. The developed method was found to be suitable to check the quality of bulk samples of Aripiprazole at the time of batch release and also during its storage (Long term and accelerated stability).

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