HPLC-ELSD同时测定得力生注射液中单糖及蔗糖含量

目的: 建立一种HPLC-ELSD方法检测得力生注射液中果糖、葡萄糖、蔗糖含量。 方法: 色谱柱:糖专用分析柱COSMOSIL Sugar-D(250 mm×4.6 mm);流动相体系:10 mmol·L^-1醋酸铵(A)-乙腈(B);流速:1 mL·min^-1,梯度洗脱;检测器:蒸发光散射检测器;柱温:30 ℃;漂移管温度:85 ℃;干燥气流速:2.1 L·min^-1。 结果: 在该条件下,果糖、葡萄糖、蔗糖都均能得到较好分离,其线性范围分别为1.024~63.98 μg、1.032~64.52 μg和0.4040~25.22 μg;平均回收率(n=9)在95%~105%,RSD均小于5%。 结论: 该方法稳定可靠,操作简便,重复性好,适于测定得力生注射液中单糖及蔗糖的含量,可为得力生注射液的质量控制提供参考。

Objective: To establish an HPLC with evaporative light scattering detection(HPLC-ELSD) method for the simultaneous quantitative analysis of fructose,glucose,sucrose in Delisheng injection. Methods: The optimal conditions of separation and detection were achieved on an analytical column specially for sugar with a mobile phase composed of a mixture of acetonitrile and 10 mmol·L^-1 ammonium acetate at a flow rate of 1 mL·min^-1 by gradient elution.Detector was ELSD and column temperature was 30 ℃.The ELSD drift tube temperature was 85 ℃ and the flow rate of the dry gas was 2.1 L·min^-1. Results: Under the above conditions,all fructose,glucose,sucrose could be well separated.The linear ranges of fructose,glucose and sucrose of 1.024-63.98 μg,1.032-64.52 μg and 0.4040-25.22 μg.The average recoveries(n=9) were 95%-105%,RSD were less than 5%. Conclusion: This method is reliable,simple and reproducible,thus it is suitable for the determination of monosaccharide and sucrose in Delisheng injection,and can provide the reference of the quality control for Delisheng injection.

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