Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF CARIPRAZINE IN BULK DRUG

Pooja Tiwari* and Purnima D. Hamrapurkar

Abstract

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the determination of Cariprazine, using a C-18 Inertsil ODS-3 (250mm×4.6mm×5μm) column and a mobile phase composed of 0.05M Ammonium Acetate Buffer : CAN (50:50,v/v), pH of buffer is 4.8 adjusted with acetic acid. The retention times of Cariprazine was found to be 5.1 min. The developed method was validated as per International Conference on Harmonization guidelines for the parameters of accuracy, precision, specificity, linearity, solution stability and system suitability. Linearity was established for Cariprazine in the range of 1-3μg/ml. The percentage recoveries of Cariprazine was found to be in the range of 98.26 - 100.47%. Cariprazine was subjected to acid, alkali hydrolysis, oxidation, thermal and photolytic degradation. The degradation studies indicated, Cariprazine to be susceptible to acid hydrolysis, base hydrolysis, oxidation and thermal degradation. The degradation products of Cariprazine in acidic, basic, oxidative and thermal conditions were well resolved from the pure drug with significant differences in the retention time values. This method can be successfully employed for quantitative analysis of Cariprazine in bulk drugs.

Keywords: Cariprazine, Stability indicating method, Degradation products, Validation.