HPLC法同时测定山楂提取物中齐墩果酸和熊果酸的含量

Simultaneous determination of oleanolic acid and ursolic acid in Hawthorn extract by HPLC

目的：采用H PLC法建立山楂提取物中齐墩果酸和熊果酸的含量测定方法，为山楂提取物的质量控制提供依据。方法 Agilent Zorbax SB C18色谱柱（250 mm ×4．6 mm ，5μm），流速0．8 ml／min ，柱温25℃，以甲醇（A）唱0．06 mol／L乙酸铵溶液（B ）（85∶15，V／V ）为流动相，等度洗脱30 min ，检测波长210 nm。结果齐墩果酸和熊果酸分别在0．496～2．480μg、0．498～9．960μg范围内与峰面积呈良好线性关系（ r＞0．9995），经重复性、精密度、加样回收率、稳定性试验，结果均符合《中华人民共和国药典》（2015年版）方法验证的要求。结论该方法可为山楂提取物及其制剂的质量控制提供依据。

Objective To establish a HPLC method for simultaneous determination of oleanolic acid and ursolic acid and provide the basis for quality control of Hawthorn extract .Methods Chromatographic separation was performed on Agilent Zorbax SB C18 column（250 mm ×4 .6 mm ,5 μm） with mobile phase of methanol （A）-0 .06 mol/L ammonium acetate solution （B） （85∶15 ,V/V ） under isocratic elution for 30 min .The flow rate was set at 0 .8 ml/min and the detection was set at the wavelength of 210 nm .Results Oleanolic acid and ursolic acid showed good linearity （r〉 0 .999 5） in the ranges of 0 .496-2.480 g and 0 .498-9 .960 g ,respectively .Repeatability ,precision ,recovery and stability were conform to the method valida-tion requirements of China Pharmacopoeia .Conclusion The method could provide the basis for the quality control of Hawthorn extract and its preparation .