Abstract

ANALYTICAL METHOD VALIDATION OF ARIPIPRAZOLE IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

*M. Vijaya Kumari, P. Eswaramma, A.V. Eswar Kumar, K. Venkata Rao, M. Narendra Babu and S.K. Shabeena Begam

ABSTRACT

A simple, isocratic with shorter runtime reverse phase high performance liquid chromatographic (RP-HPLC) method for Assay of Aripiprazole and validated for the determination Aripiprazole activity in Aripiprazole tablet formulation. Separation of Aripiprazole was successfully achieved on C18 Inertsil ODS 3V(150x4.6mm i.d.,5μm) column in isocratic mode using mobile phase composition of mix Acetonitrile : buffer in the ratio of (40:60 ) V/V with flow rate of 0.8 ml / min and the eluate was monitored using PDA Detector at 215 nm. The retention time was found to be 8min for Aripiprazole. The proposed method was is found to be linearity in the concentration range 150 to 450ppm with correlation coefficient 1.000.The developed method was validated as per ICH guidelines for specificity, linearity and precision, accuracy, ruggedness and robustness. The results of all the validation parameters were well within their acceptance values. The method gave good % recovery with in the range of 97.89% to 103.7% for the given Tablet dosage form when it was applied for its determination in pharmaceutical dosage form. The method also may be extended to the bulk drug substances.

Keywords: Aripiprazole; RP-HPLC; Isocratic method.