Separation, Characterization and quantification of Impurities and Identification of stress degradants of Cabazitaxel by RP-HPLC and LC-ESI-MS techniques

Abstract

Cabazitaxel is a natural taxoid used to treat prostate cancer in advanced stage. The authors have separated and identified seven impurities of Cabazitaxel using RP-HPLC and LC-MS techniques. Gradient mode was chosen for the separation of impurities in presence of Cabazitaxel and the method was validated as per the International Conference on Harmonization guidelines. The impurities were quantified in the present study and the plausible degradation path was also proposed. Stress degradation studies were performed and the degradants obtained were characterized with the help of mass spectra. Shimadzu HPLC prominence coupled with MS Spectrometry (THERMO) with Sunfire C18 column (100x 4.6 mm, 3.5 μm particle size) was used for performing the chromatographic separation with 0.05% formic acid and acetonitrile mixture as mobile phase with flow rate 1.0 ml/min. The injection volume 10μL and wavelength was monitored at 220 nm). The method was applied to the pharmaceutical formulation to study the suitability of the method. The method is very much useful for the pharmacokinetic studies as well as the metabolites study in vitro and in vivo of cancer patients.