Abstract

SIMULTANEOUS DETECTION AND IDENTIFICATION OF DRUG RELATED IMPURITIES IN PREDNISOLONE AND ABIRATERONE ACETATE

Mr. B. S. Rajpurohit*, Mr. K. J. Suthar, Mr. V. T. Chudasma, Miss. M. K. Patel, Dr. Prajesh Prajapati, Dhara Kaneria, Riddhi Trivedi

ABSTRACT

A simple, precise, accurate method has accomplished by high performance liquid chromatography for separation and identification of degradant impurities in Abiraterone acetate (AA) and Prednisolone (PD). The chromatographic separation of drug and their related impurities were performed on inertsil ODS-3 μm C 18, 150mm × 4.6mm while the binary elution using mobile phase methanol: 0.1% formic acid in water (90:10 v/v) at a flow rate of 0.5 ml/min for achieving better separation of peaks. The separation was performed by HPLC gradient at wavelength of 254nm and identification of degradants were performed in LC-MS study. The Retention time of Abiraterone acetate and Prednisolone were found at 6.4min and 3.0min, the linearity was found to be in range of 10-30μg/ml, LOD and LOQ was found at 50 and 152 ng for Abiraterone acetate and 102 and 311 ng for Prednisolone respectively.

Keywords: Abiraterone acetate, Prednisolone, HPLC, LC-MS, Degradant impurity.