RP-HPLC法同时测定甘草酸制剂中18α-、18β-甘草酸的含量

目的: 建立RP-HPLC法同时测定甘草酸制剂中18α-、18β-甘草酸的含量。 方法: 采用Phenyl-Hexyl(4.6 mm×250 mm,5 μm)色谱柱,流动相为10 mmol·L^-1醋酸铵溶液(pH=7.75)-乙腈(83∶17),流速1.0 mL·min^-1,柱温38 ℃,检测波长250 nm。 结果: 18α-、18β-甘草酸的线性范围均为0.3~80 μg·mL^-1(r²分别为0.9998和0.9999)。两差向异构体得到良好的分离,各制剂中异构体的组成比各不相同。 结论: 该方法准确,简便,重复性好,可为控制甘草酸制剂中18α-甘草酸和18β-甘草酸的质量标准提供参考,为对18α-甘草酸和18β-甘草酸的进一步研究奠定了基础。

Objective: The aim of the present study was to simultaneously determine 18α-and 18β-glycyrrhizic acid in glycyrrhizin preparations. Method: The chromatographic analysis was carried out on a Phenyl-Hexyl Column (4.6 mm×250 mm,5 μm) with the mobile phase consisting of 10 mmol·L^-1 ammonium acetate (pH 7.75)-acetonitrile (83∶17) at a flow-tate of 1.0 mL·min^-1.Temperature:38 ℃.The detection wavelength was 250 nm. Result: Linearity range of 18α-and 18β-glycyrrhizic acid were both 0.3-80 μg·mL^-1(r² were 0.9998 and 0.9999,respectively).Two epimers were well separated and the composition ratios of them in different glycyrrhizin preparations were different. Conclusion: The method is accurate,simple and reproducible.This method could reference the quality control standard for 18α-and 18β-glycyrrhizic acid in glycyrrhizin preparations and lay the foundation for further research.