超高效液相色谱法同时测定参麦注射液中11个成分的含量

目的：建立了同时测定参麦注射液中11个人参皂苷含量的超高效液相色谱方法，并对参麦注射液样品进行含量测定。方法：采用Aglient Eclipse plus C₁₈（ 2.1 mm×50 mm，1.8 μm）色谱柱，乙腈-水为流动相，梯度洗脱，流速0.3 mL·min^-1，柱温30℃，检测波长203 nm。结果：人参皂苷Rg₁、Re、Rf、Rb₁、Rc、Rb₂、Rb₃、Rd、20（S）-人参皂苷Rh₁、20（S）-人参皂苷Rg₂、20（S）-人参皂苷Rg₃的线性范围分别为0.095~0.380 mg·mL^-1（r=0.992 3）、0.055~0.220 mg·mL^-1（r=0.992 2）、0.025~0.099 mg·mL^-1（r=0.999 9）、0.004~0.019 mg·mL^-1（r=0.999 3）、0.005~0.022 mg·mL^-1（r=0.999 4）、0.156~0.626 mg·mL^-1（r=1.000）、0.067~0.268 mg·mL^-1（r=1.000）、0.058~0.234 mg·mL^-1（r=1.000）、0.007~0.031 mg·mL^-1（r=0.999 8）、0.032~0.130 mg·mL^-1（r=1.000）、0.007~0.028 mg·mL^-1（r=0.999 2），平均加样回收率（n=6）为91.4%~100.8%，RSD为0.34%~3.4%。样品中上述11个人参皂苷的含量范围分别为0.138 7~0.173 0、0.086 8~0.108 7、0.033 0~0.043 5、0.009 9~0.013 4、0.011 0~0.016 0、0.175 8~0.295 4、0.085 0~0.133 9、0.066 6~0.118 4、0.008 4~0.015 0、0.033 3~0.065 5、0.009 5~0.016 8 mg·mL^-1。结论：该方法重复性好，稳定可控，可用于参麦注射液中人参皂苷类成分的含量测定。 

Objective:To establish quantitative method for simultaneous determination of eleven components in Shenmai injection by ultra high performance liquid chromatography(UHPLC),and to perform assay of Shenmai injection. Methods:The analysis was performed on a Aglient Eclipse plus C₁₈(2.1 mm×50 mm,1.8 μm) column. The column temperature was 30℃. The mobile phase consisted of acetonitrile and water with gradient elution at a flow rate of 0.3 mL·min^-1. The UV detection wavelength was set at 203 nm. Results:The linear ranges of ginsenosides Rg₁,ginsenosides Re,ginsenosides Rf,ginsenosides Rb₁,ginsenosides Rc,ginsenosides Rb₂,ginsenosides Rb₃,ginsenosides Rd,20(S)-ginsenosides Rh₁,20(S)-ginsenosides Rg₂ and 20(S)-ginsenosides Rg₃ were 0.095-0.380 mg·mL^-1(r=0.992 3),0.055-0.220 mg·mL^-1(r=0.992 2),0.025-0.099 mg·mL^-1(r=0.999 9),0.004-0.019 mg·mL^-1(r=0.999 3),0.005-0.022 mg·mL^-1(r=0.999 4),0.156-0.626 mg·mL^-1(r=1.000),0.067-0.268 mg·mL^-1(r=1.000),0.058-0.234 mg·mL^-1(r=1.000),0.007-0.031 mg·mL^-1(r=0.999 8),0.032-0.130 mg·mL^-1(r=1.000) and 0.007-0.028 mg·mL^-1(r=0.999 2),respectively. The mean recoveries(n=6) were in the range of 91.4%-100.8% with RSDs of 0.34%-3.4%. The contents of above-mentioned eleven constituents in samples were 0.138 7-0.173 0,0.086 8-0.108 7,0.033 0-0.043 5,0.009 9-0.013 4,0.011 0-0.016 0,0.175 8-0.295 4,0.085 0-0.133 9,0.066 6-0.118 4,0.008 4-0.015 0,0.033 3-0.065 5 and 0.009 5-0.016 8 mg·mL^-1. Conclusion:The established UHPLC method is reproducible,stable and controllable,which can be used to determine the eleven ginsenosides in Shenmai injection.

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