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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: To study the retention behavior of ondansetron hydrochloride enantiomers on cellulose derivatives and protein stationary phase, optimize the chromatographic conditions and determine the dextrose isomers (S) in lev- content. Methods: Chiralcel OJ and Ultron ES-OVM were used as stationary phase. The mobile phase consisted of n-hexane-ethanol-diethylamine (60:40:0.1) and 10mmol·L-1 ammonium formate buffer (95: 5). The detection wavelength was 245nm and 249nm respectively, and the factors affecting the separation were investigated. Results: Ondansetron hydrochloride enantiomers achieved baseline separation in both of the above two chiral stationary phases. The detection limits of ondansetron enantiomers were 3 ng (Chiralcel OJ) and 6 ng (Ultron ES-OVM), respectively. CONCLUSION: The enantiomers of ondansetron hydrochloride can be easily separated by the established method and the content of dextro isomers in the raw materials and injection of levonistone hydrochloride.