Determination of Related Substances in Cabazitaxel Injection by HPLC
10.6039/j.issn.1001-0408.2018.09.14
- VernacularTitle:高效液相色谱法测定卡巴他赛注射液的有关物质
- Author:
Ju FENG
1
;
Fengying REN
;
Chen YANG
;
Jianghong LI
;
Xijia WANG
;
Lin CHEN
;
Kejin SHI
Author Information
1. 药食同源植物资源开发四川省高校重点实验室/四川抗菌素工业研究所/成都大学
- Keywords:
Cabazitaxel injection;
HPLC;
Related substance;
Gradient elution
- From:
China Pharmacy
2018;29(9):1209-1212
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the determination of related substances in Cabazitaxel injection. METHODS:HPLC method was used. The determination was performed on Agilent Eclipse XDB-C18column with mobile phase consisted of water-acetonitrile-ethanol(gradient elution)at the flow rate of 1.0 mL/min. The column temperature was 35 ℃,and the detection wavelength was set at 230 nm. The sample size was 20 μ L. Established method was used to determine related substances in 3 batches of Cabazitaxel injection. RESULTS:The linear relationship of cabazitaxel were 0.039-11.60 μ g/mL(r=0.999 8,n=7). The detection limit was 2×10-4μg,and quantitation limit was 8×10-4μg. RSD of precision and reproducibility tests were all lower than 10.0%(n=6). The amount of single impurity in 3 batches of samples ranged 0.07%-0.08%,and total amount of impurities were 0.26%-0.29%. CONCLUSIONS:Established method is simple,accurate and reliable,can be used for the determination of related substances in Cabazitaxel injection.
