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

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 mass spectroscopic method to stress degradation behavior abiraterone under various conditions along with its validation. The separation major product achieved Capcell PAK C18 MG-III (100×4.6 mm, 3 μm) column using combination 0.1 % acetic acid acetonitrile as mobile phase flow rate 1.2 ml/min wavelength detection selected 251 nm. drug was degraded extensively acidic basic hydrolysis. A tentative pathway alkaline condition predicted. developed analytical found selective, accurate, precise robust accordance International Council for Harmonization guidelines. will also suffice suitability assay bulk finished products.