Analytical Stress Degradation Studies of Cabazitaxel (A Semi synthetic Natural Taxoid) using Liquid Chromatography

Abstract

Cabazitaxel, asemi-synthetic derivative of the natural taxoid used to treat advanced prostate cancer. A simple validated stability-indicating liquid chromatographic method has been developed for the determination of Cabazitaxel in pharmaceutical formulations using Shimadzu Model CBM-20A/20 AliteHPLC system equipped with PDA detector and Zorbax SB-C18 column (150 mm × 4.6 mm i.d., 3.5 µm particle size) with a mixture of tetra butyl ammonium hydrogen sulphateand acetonitrile (30:70, v/v) as mobile phase (UV detection 231 nm; flow rate 1.2 ml/min). Stress conditions studies such asacidic, alkaline, oxidation photolytic and thermal degradations have been performed and the method was validated as per ICH guidelines. Key words: Cabazitaxel, RP-HPLC, Stability-indicating, Validation, ICH guidelines.