目的:建立以α1-酸性糖蛋白(α1-AGP)为手性固定相的高效液相色谱法直接拆分克仑特罗光学对映体。方法:优化色谱条件,研究了流动相中有机改性剂的种类、含量、流动相的pH、缓冲盐溶液的浓度和流速等因素对拆分的影响。结果:最佳色谱条件:流动相为异丙醇-0.01mol·L^-1磷酸盐缓冲液(VII5.0)(1:99),流速为0.8mL·min^-1,紫外检测波长为213nm,柱温为25℃。结论:用α1-酸性糖蛋白柱可有效地分离克仑特罗光学对映体,所建立的方法具有简便、快速的优点,可用于制剂中克仑特罗光学对映体的测定。
Objective: To establish an HPLC method to directly separate clenbuterol enantiomers on α1-acid glycoprotein chiral column. Methods:The effects of chromatographic conditions including pH of mobile phase, ionic strength,type and concentration of organic modifiers, flow rate on chiral separation were studied. Results:The optimized chromatographic conditions were as follows : admixture of isopropanol - 0.01 mol · L^-1 phosphate buffer( pH 5.0) (1:99)as the mobile phase ,flow rate 0.8 mL · min^-1, detection wavelength 213 nm, column temperature 25 ℃. Conclusions:The established method is proved to be fast and convenient. Clenbuterol enantiomers can be separated with high resolution factor by using α1-acid glycoprotein column.