Validated RP-HPLC Method for Analysis of Aripiprazole in a Formulation

Abstract

A rapid, simple and validated reversed-phase high-performance liquid chromatographic method has been developed for analysis of aripiprazole in tablet dosage form. Aripiprazole was separated on an ODS analytical column with a 40:60 (v/v) mixture of acetonitrile and triethanolamine buffer (5 mM, pH 3.5 ± 0.05 adjusted by addition of 85% phosphoric acid) as mobile phase at a flow rate of 1.5 mL min-1. The effluent was monitored by UV detection at 254 nm. Calibration plots were linear in the range of 20 to 60 µg mL-1 and the LOD and LOQ were 0.411 and 1.248 µg mL-1, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of aripiprazole in tablets.