中兽医医药杂志2025，Vol.44Issue(3)：60-62,3.DOI:10.13823/j.cnki.jtcvm.2025.022
超临界流体色谱法测定富马酸贝达喹啉中的对映异构体
Determination of enantiomer imputity in Bedaquiline Fumarate by supercritical fluid chromatography
摘要
Abstract
This study aimed to establish a SFC(Supercritical Fluid Chromatography)method to determine the enantiomer impurity in Bedaquiline Fumarate.The separation was carried out on a CHIRALPAK®IC-3(4.6 mm×150.0 mm,3µm)column,the mobile phase CO2 was used as the mobile phase A and 750 mL isopropanol+250 mL acetonitrile+2 mL ammonia as the mobile phase B.Gradient elution was used.The detector was ultraviolet absorption detector.The flow rate was 2.5 mL/min.The result showed the correlation coefficient(r)of the enantiomer impurity in the concentration range 0.498 5-5.981 6 µg/mL was 0.999 6.The limit of detection was 0.149 6 µg/mL,and the limit of quantification was 0.498 5 µg/mL,the recoveries were 94.97%-102.74%.The experiment showed that the method is rapid,simple,sensitive and accurate for the quantitative determination of enantiomer impurity in Bedaquiline Fumarate.关键词
超临界流体色谱/富马酸贝达喹啉/对映异构体/杂质Key words
supercritical fluid chromatography(SFC)/Bedaquiline Fumarate/enantiomer/impurity分类
畜牧业引用本文复制引用
冯秀珍,孙鹏,陈立茹,蔡建光,阳凯,邱林松,阮荷玲,和燕玲,邵伍军..超临界流体色谱法测定富马酸贝达喹啉中的对映异构体[J].中兽医医药杂志,2025,44(3):60-62,3.基金项目
台州市科学技术局(24nya17,24gyb20) （24nya17,24gyb20）
