手性高效液相色谱法测定虫酰肼原药中的异构体杂质

Analysis of Isomer Impurity in Tebufenozide TC by Chiral HPLC

采用高效液相色谱法,使用Chiralcel OD-H手性柱,对虫酰肼原药中主成分与异构体进行了分离,并对异构体杂质进行了定量分析。结果表明,该方法分析异构体杂质的线性相关系数为0.9997,变异系数为0.25%,回收率在98.57%～101.47%之间。

A quantitative analytical method for isomer impurity in tebufenozide TC was established by chiral HPLC using Chiralcel OD-H column. The results showed that the linear correlation coefficient was 0.999 7, the coefficient of variation was 0.25%, and the recoveries were between 98.57% and 101.47%.