Stability Indicating RRLC Method for Determination of Aripiprazole and its Intermediates in Bulk and Pharmaceutical Formulation

An Rapid Resolution Liquid Chromatographic method (RRLC) has been developed and subsequently validated for the determination of Aripiprazole and its intermediates in bulk and pharmaceutical formulation. Separation was achieved with a Hypersil gold, C18, 50×4.6 mm, 5 μm column with Mixture of Potassium Dihydrogen Phosphate and Triethylamine (pH adjusted to 3.0±0.05 with Orthophosphoric acid):Acetonitrile:Methanol (60:20:20 ,v/v) as eluent at a flow rate 1.0 ml/min. UV detection was performed at 252 nm. The method is simple, rapid, selective and stability indicating. The described method is linear over a range of 30.507 μg/mL to 183.040 μg/mL. The method precision for the determination of assay was below 2.0% RSD. The Percentage recoveries of Active Pharmaceutical Ingredient (API) from dosage forms ranged from 97.4 to 100.2 for all available strengths of Arpiprazole in market. LOD and LOQ of all related impurities of Aripiprazole was established and ranged from 0.015 μg/ml-0.034 μg/ml for LOD and 0.04 μg/ml-0.101 μg/ml for LOQ. The method is useful in the quality control of bulk manufacturing and also in pharmaceutical formulations.