中国药房2018，Vol.29Issue(9)：1209-1212,4.DOI:10.6039/j.issn.1001-0408.2018.09.14
高效液相色谱法测定卡巴他赛注射液的有关物质
Determination of Related Substances in Cabazitaxel Injection by HPLC
摘要
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.关键词
卡巴他赛注射液/高效液相色谱法/有关物质/梯度洗脱Key words
Cabazitaxel injection/HPLC/Related substance/Gradient elution分类
医药卫生引用本文复制引用
冯菊,任凤英,杨晨,李江红,汪锡佳,陈林,石克金..高效液相色谱法测定卡巴他赛注射液的有关物质[J].中国药房,2018,29(9):1209-1212,4.基金项目
四川省科技计划项目(No.2017HH0011) （No.2017HH0011）
药食同源植物资源开发四川省高校重点实验室开放基金项目(No.10Y201609) （No.10Y201609）
