【摘要】 目的:建立泮托拉唑对映体拆分和对映体光学纯度测定方法。方法:用α1-酸糖蛋白手性固定相,考察了缓冲液的种类和pH、有机改性剂的种类和比例、流速及柱温对泮托拉唑对映体拆分的影响。采用Chiral-AGP柱(150 mm×4.6 mm,5μm,配有手性AGP预柱),以10 mmol·L-1醋酸铵缓冲液(pH 5.5)-乙腈(93:7)为流动相,在流速为0.9 mL·min-1,检测波长为290 nm,柱温为20℃的条件下拆分泮托拉唑对映体。结果:用α1-酸糖蛋白手性固定相能完全分离泮托拉唑对映体,分离度达1.77,并测定了泮托拉唑对映体过量百分率。结论:流动相pH和有机改性剂含量是影响对映体分离的重要因素,可以以调节流速和柱温来提高柱效、改善分离。更多还原

【Abstract】 Objective:To develop a chiral separation method for the enantiomers of pantoprazole. Method:Influences of the pH value of the mobile phase, the organic modifiers, the flow rate and the column temperature on the enantiomeric separation of pantoprazole using α1 - acid glycoprotein chiral stationary phase were investigated. Pantoprazole enantiomers were separated on a Chiral -AGP column (150 mm ×4. 6 mm, 5μm)with a mobile phase consisted of 10 mmol· L-1 NH4OAc ( pH 5. 5 ) - acetonitrile (93: 7) at a flow rate of 0. 9 mL· min-1. Results: Pantoprazole enantiomers were separated on an α1 - acid glycoprotein chiral stationary phase and the resolution was 1. 77. The values of enantiomeric excess of pantoprazole were determined under optimized conditions. Conclusion: The pH value of the mobile phase, the organic modifer concentration, the flow rate and the temperature of column were very important when optimizing the enantiomeric separation of pantoprazole.更多还原