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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-0.01 mol.L-1磷酸盐缓冲液(pH 5.0)(1∶99),流速为0.8 mL.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 direct optical resolution of clenbuterol by HPLC with α1-acidic glycoprotein (α1-AGP) as chiral stationary phase. Methods: The chromatographic conditions were optimized. The effects of organic modifiers, such as the type and content of mobile phase, the pH of mobile phase, the concentration of buffer solution and the flow rate on the resolution were studied. Results: The optimum chromatographic conditions were as follows: isopropanol-0.01 mol·L-1 phosphate buffer (pH 5.0) 1:99, flow rate 0.8 mL.min-1, UV detection wavelength 213 nm, The temperature is 25 ° C. Conclusion: The enantiomers of clenbuterol can be effectively separated by α1-acid glycoprotein column. The established method is simple and rapid and can be used for the determination of clenbuterol optical enantiomers.