DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR CARIPRAZINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Ranjit Shelake, Sujit Karpe, Sakshi Gavali, Amruta Tavse, Mayuri Nagtilak, *Sayali Yawalkar, Vishal Sannake and Amol Sagade

A simple, accurate, precise, rapid and specific reverse phase HPLC method has been developed for the estimation of Cariprazine in bulk and pharmaceutical dosage forms. The chromatographic separation was achieved on Agilent Zorbax SB-Aq (250 x 4.6mm, 5μ) column. The mobile phase consisted of Acetonitrile: Buffer (50:50 % v/v) at a flow rate 1.0ml/min with diluent Acetonitrile: Water (50:50). The analyte was monitored using UV at 216nm and run time was kept 10min. The column temperature was adjusted at 30ºC with injection volume 10μl. The retention time of Cariprazine was 3.57 min. Linearity was found to be in concentration range of 80-120μg/ml. Cariprazine was checked for its suitability, specificity and other validation parameters. Results of study were valid statistically and by recovery studies. The method was validated according to the ICH guidelines with relevancy to accuracy, precision, specificity and linearity.