Development of Stability Indicating Reverse Phase HPLC Method for Aripiprazole from Solid Dosage form

Aripiprazole is a novel antipsychotic drug, generally used in schizophrenia and known to act as a partial agonist at D2 and 5 –HT2A receptors. Since stability indicating method is required to discriminate between the intact analyte and degradation products, the present work is aimed at performing purposeful degradation of aripiprazole by exposing it to various pH conditions, oxidative conditions, dry heat and sunlight. Also it describes the final method of analysis of aripiprazole from the tablets. The chromatographic analysis was carried out on HiQSil C8 column (250 X 4.6 mm, 5 µm), mobile phase was Acetonitrile: Potassium Phosphate buffer (pH =3, 100 mM), (40:60 V/V); injection volume 100 µL, detection was carried out at λmax 225nm. Flow rate was 1.0 ml/min. The developed stability indicating method for aripiprazole was validated as per International Conference on Harmonization (ICH) guidelines.