HPLC法同时测定注射用艾迪(冻干)中人参皂苷Rg_1和人参皂苷Re的含量

HPLC simultaneous determination of ginsenoside Rg_1 and ginsenoside Re in Aidi freezing dried powder for injection

目的:建立注射用艾迪(冻干)中人参皂苷Rg_1和人参皂苷Re的含量测定方法。方法:色谱柱为Hypersil C_(18)柱(250mm×4.6mm,5μm),流动相为乙腈-0.05%磷酸溶液(19∶81),流速为1.0mL·min^(-1),检测波长为203nm。结果:人参皂苷Rg_1浓度在20～200μg·mL^(-1),人参皂苷Re浓度在10～100μg·mL^(-1)范围内与峰面积呈良好的线性关系,相关系数分别为0.9997和0.9996;平均回收率分别为100.3%和97.6%(n=9)。结论:本法快速,准确,重复性好,可作为注射用艾迪(冻干)的质量控制方法。

Objective： To develop an HPLC method for the determination of ginsenoside Rg1 and ginsenoside Re in Aidi freezing dried powder for injection. Method： Chromatographic assay was performed on Hypersil C18 column （250 mm×4.6mm,5μm） with acetonitrile -water containing 0. 05% phosphoric acid （19：81 ） as mobile phase. The flow rate was 1.0 mL ·mL^-1 and the detection wavelength was 203 nm. Results：Ginsenoside RgI had a good linearity （ r = 0. 9997 ） in the range of 20 - 200μg·mL^-1. The mean recovery was 100. 3% （ n = 9）. Ginsenoside Re had a good linearity （r =0. 9996） in the range of 10 - 100 μg·mL^-1. The mean recovery was 97.6% （n = 9）. Conclusion： The method is simple, sensitive and accurate. It can be used for quality control of Aidi freezing dried powder for injection.