Study on Stress Degradation Behaviour of Abiraterone Acetate in Film Coated Tablets and Identification of Major Stress Degradation Product by LC-UV-ESI-MS

Abstract

Abiraterone acetate is an androgen biosynthesis inhibitor used in the treatment of prostate cancer. This study focuses on a simple, economical and systematic liquid chromatographic and mass spectroscopic method to study the stress degradation behavior of abiraterone acetate under various stress conditions along with its validation. The chromatographic separation of abiraterone acetate and its major degradation product is achieved on Capcell PAK C18 MG-III (100×4.6 mm, 3 μm) column using combination of 0.1 % acetic acid and acetonitrile as mobile phase with a flow rate of 1.2 ml/min and the wavelength of detection is selected as 251 nm. The drug was degraded extensively in acidic and basic hydrolysis. A tentative degradation pathway of drug in acidic and alkaline condition was predicted. The developed analytical method was found selective, accurate, precise and robust in accordance with International Council for Harmonization guidelines. The method will also suffice the suitability for the assay of abiraterone acetate in bulk and finished products.