摘要
目的:采用高效液相色谱法拆分奥硝唑对映体,并对左旋奥硝唑原料药进行其右旋异构体的检查。方法:使用Daicel Chiralcel OB-H手性固定相色谱柱,流动相为正己烷-异丙醇-甲醇(95∶1∶4),进样体积5μL,柱温30℃;流速0.8mL·min^(-1),检测波长311nm,并考察了流动相的组成、流速等色谱条件对分离的影响。结果:在上述色谱条件下,奥硝唑对映体的分离度大于1.86,原料药中未检出右旋体杂质。结论:本方法可以实现奥硝唑的手性分离,并能应用于左旋奥硝唑原料药中的右旋体杂质的控制。
The separation of enantiomers of ornidazole was performed by HPLC, and the impurity of dextroisomer in S- ornidazole was detected. Method：The Daicel Chiralcel OB -H CSP column was applied with the mo- bile phase consisting of n -hexane -isopropyl alcohol -methanol （95： 1：4）, injection volume was 5 μL, column temperature was 30 ℃ ,flow rate was 0. 8 mL · min^ -1 and wavelength was 311 nm. The composition of mobile phase and flow rate were studied. Results：The resolution of enantiomers was more than 1.86 and there was no impurity of dextroisomer being detected under this chromatographic condition. Conclusion：The method can be used for separating the enantiomers of ornidazole and controlling of the impurity of dextroisomer in S - ornidazole substances.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第4期532-534,共3页
Chinese Journal of Pharmaceutical Analysis
关键词
奥硝唑
手性拆分
杂质检查
ornidazole
chiral separation
impurity test
