蛋白质及纤维素衍生物手性固定相分离盐酸昂丹司琼对映体  

Enantiomers separation of ondansetron hydrochloride using proteinate-and amylase-based chiral stationary phase

作　　者：尹燕杰[1] 张启明[2] 田颂九[2] 

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150525 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2009年第6期971-974,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:研究盐酸昂丹司琼对映体在纤维素衍生物及蛋白质固定相上的保留行为,优化色谱条件,并测定盐酸左昂丹司琼(R)中右旋异构体(S)的含量。方法:Chiralcel OJ和Ultron ES-OVM为固定相时,流动相分别为正己烷-乙醇-二乙胺(60∶40∶0.1)和10mmol·L-1甲酸铵缓冲液(pH4.8)-乙腈(95∶5);检测波长分别为245nm和249nm,并考察了影响分离的因素。结果:盐酸昂丹司琼对映体在上述2种手性固定相均达到基线分离。昂丹司琼对映体的检测限分别为3ng(Chiralcel OJ)和6ng(Ultron ES-OVM)。结论:所建立的方法均可方便地分离盐酸昂丹司琼对映体并测定盐酸左昂丹司琼原料和注射液中右旋异构体的含量。Objective：HPLC methods were developed for the separation of the enantiomers of ondansetron hydrochloride using derivatized cellulose and protein chiral stationary phases and the methodology for detection of impurity of S - ondansetron in R - ondansetron injection and raw material is established. Methods： The separation were performed on Chiralcel OJ and Ultron ES -OVM with the mobile phase being hexane -alcohol- diethylamine （60 ： 40：0.1 ） and 10 mmol · L^-1 ammonium formate buffer solution （ pH 4. 8 ） - acetonitrile （95：5 ）, respectively. The detective wavelength was 245 nm and 249 nm, respectively. Several parameters on separation were studied. Results： Baseline separation was easily obtained in all cases. LOD of ondansetron enantiomers were 3 ng（ Chiralcel OJ）and 6 ng（ Uhron ES - OVM ）. Conclusion ： All the methods developed in this study can be used for separation and quantitation of enantiomers of ondansetron hydrochloride conveniently.

关 键 词：对映体分离 昂丹司琼 HPLC 手性固定相 

分 类 号：R917[医药卫生—药物分析学]