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目的:建立高效液相色谱测定参麦注射液中人参皂苷Rg1和人参皂苷Re的方法。方法:采用Bon Chrome C18(4.6mm×250mm,5μm);流动相A相为0.1mol/L的KH2PO4溶液,B相为乙腈∶水=75∶25,PH=3.5进行梯度洗脱,流速为1.0mL/min,检测波长为203nm;柱温为38℃。结果:参麦注射液中人参皂苷Rg1在0.4175～2.0496μg范围内与峰面积线性关系良好(r=0.9998),平均加样回收率为98.40%(RSD为0.58%);人参皂苷Re在0.4864～2.473μg范围内与峰面积线性关系良好(r=0.9997),平均加样回收率为98.67%(RSD为0.53%)。结论:HPLC测定参麦注射液中人参皂苷Rg1和人参皂苷Re含量,其结果准确、灵敏度高、重现性好,操作简单、方法可靠,可以作为参麦注射液产品质量控制的方法之一。
Objective: To establish a HPLC method for the determination of ginsenoside Rg1 and ginsenoside Re in Shenmai injection. METHODS: The mobile phase consisted of a 0.1% KH2PO4 solution of mobile phase A, acetonitrile (B): water (75:25) and pH = 3.5 mL / min, detection wavelength was 203nm; column temperature was 38 ℃. Results: The ginsenoside Rg1 in Shenmai injection had a good linear relationship with the peak area (r = 0.9998) in the range of 0.4175 ~ 2.0496μg, with an average recovery of 98.40% (RSD 0.58%); ginsenoside Re was 0.4864 ~ The linear range of 2.473μg was linear with the peak area (r = 0.9997). The average recovery was 98.67% (RSD 0.53%). Conclusion: The HPLC method for the determination of ginsenoside Rg1 and ginsenoside Re in Shenmai injection has the advantages of accurate results, high sensitivity, good reproducibility, simple operation and reliable method, which can be used as one of the methods for quality control of Shenmai injection.