Study On The Quality Evaluation And Method Of Cabazitaxel Raw Materials And Their Injections

Cabazitaxel is a chemical semi-synthetic taxane small molecule compound belonging to the taxane anticancer drugs, developed by Sanofi-aventis in France for the second-line treatment for prostate cancer. It can be used in combination with Prednisone to treat refractory metastatic prostate cancer patients who are failed in Docetaxel therapy containing hormone. The drug has a huge market potential to serve patients better.In accordance with the guidelines of the 2015 edition Chinese Pharmacopoeia,this work characterizes the Cabazitaxel raw medicine first, and then qualitative identifis the Cabazitaxel by using high performance liquid chromatography (HPLC),powder x-ray diffraction (PXRD), differential scanning calorimetry (DSC) and other analytical methods.The specification of Docetaxel in 8th European Pharmacopoeia reference is employed to establish the quality standard of Cabazitaxel, such as character,identification and inspection of inorganics etc. In this work, we also develop a HPLC method to determine the content of Cabazitaxel and Cabazitaxel related substance,providing a theoretical basis for Cabazitaxel injection standard.On the basis of Cabazitaxel quality studies, the quality standard of Cabazitaxel injection has also established. The determination of Cabazitaxel injection related substances by HPLC method is also established by careful study of the chromatographic conditions. The method has been verified by means of system suitability test, specificity test, solution stability and other methods, thus ensuring the feasiblity and accuracy of the methodTo make sure the Cabazitaxel is stable, effective and controllable, the con-tent of related substances and main components as well as other influence fact-ors are investigated.The results may serve a base for next studying of the Cabazitaxel.