高效液相色谱法测定熊果酸原料中有关物质含量

Determination of Related Substances in Raw Materials of Ursolic Acid by HPLC

目的建立高效液相色谱(HPLC)法测定熊果酸原料中的有关物质含量,为制定其质量标准提供依据。方法采用Agilent XDB-C18(250 mm×4.6 mm,5μm)色谱柱,流动相为水相[水∶三乙胺∶冰醋酸(10∶0.03∶0.06)]与甲醇系统,梯度洗脱,检测波长210 nm,柱温30℃,流速1.0 mL·min-1,进样量20μL。结果熊果酸中齐墩果酸含量均<0.5%;其他杂质均未检出。结论该方法可以作为熊果酸原料中的有关物质的检查方法,简便,快速,准确,专属性好。

Objective To establish a method for determination of related substances of ursolic acid raw materials and provide the evidence for its quality control.Methods The chromatographic column was Agilent XDB-C18（250 mm×4.6 mm,5 μm）.The mobile phase consisted of methanol-water phase [water：triethylamine：glacial acetic acid（10：0.03：0.06）].The gradient elution was applied as a chromatographic separation,and the detection wavelength was set at 210 nm.Results The oleanolic acid contained in the ursolic acid was less than 0.5%,and other impurities were not detected.Conclusion This method is simple,rapid,accurate and has a good specificity that can be used in checking the related substances in raw materials of ursolic acid.