Abstract

STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF ANTI- PSYCHOTIC DRUG CARIPRAZINE IN BULK DRUG PHARMACEUTICAL FORMULATION

Sandeep Chaudhary, Dr. Prabodh Chander Sharma*, Dr. Meenakshi Dahiya, Dr. Rajeev Singh Raghuvanshi, Ashu Rathi, and Dr. Prabodh Chander Sharma

ABSTRACT

The aim of present research work is to develop stability indicating validated RP-HPLC method for the determination of Anti-Epileptic drug “Cariprazine” in Pharmaceutical bulk form. A Simple, Economic, Accurate, Sensitive and Precise RP-HPLC method was developed for Anti-Psychotic drug Cariprazine. The method was developed by using Inertsil C18 (250mm×4.5mm, 5μm) column and For the mobile phase buffer is mixed with ACN in ratio of (60:40) is selected. Buffer is prepared by Mixture of 3g of ammonium acetate in HPLC Grade Water(1000mL) and pH was adjusted to 4 with glacial acetic acid and this buffer is mixed with ACN in ratio of (60:40) respectively. The Retention time for Cariprazine was found to be 7.02 min. Linearity range for Cariprazine was found to be 40-60 μg/ml and the Regression equation was found to be y=24254x + 79458 . The value of Linearity regression coefficient was found to be R2 = 0.997. % RSD for inter and intra-day precision was found to be 0.18% and 0.21%. The result are analysed statistically and are found to be satisfactory. Hence this method can be successfully employed for analysis of Anti-Psychotic drug Cariprazine in Bulk form.

Keywords: CARIPRAZINE, RP-HPLC, %RSD, PPM.