苦碟子注射液中果糖、葡萄糖和蔗糖的含量测定

Content determination of fructose,glucose and sucrose in Kudiezi injection by HPLC-ELSD

目的采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)测定苦碟子注射液中果糖、葡萄糖和蔗糖的含量。方法采用Prevail Carbohydrate ES糖分析色谱柱(4.6 mm×250 mm,5μm),乙腈(B)-0.1%乙酸水(A)为流动相,线性梯度洗脱,流速为1.0 mL·min-1,柱温为25℃;ELSD检测器:漂移管温度为80℃,雾化气(空气)流速为1.8 L·min-1,测定苦碟子注射液中果糖、葡萄糖和蔗糖含量。结果果糖、葡萄糖和蔗糖在色谱柱上分离效果良好,其平均加样回收率分别为96.7%(RSD=0.70%)、96.6%(RSD=1.3%)、98.6%(RSD=2.9%)。结论该方法简便、稳定、重复性好,可用于苦碟子注射液中果糖、葡萄糖和蔗糖测定,并为其质量控制提供理论依据。

Objective To establish an HPLC-ELSD method to determine the content of fructose, glucose and sucrose in Kudiezi injection. Methods Chromatographic separation was performed on a Prevail Carbohydrate ES column with the mobile phase of acetonitrile（B）-0.1% acetic acid（A） at a fl ow rate of 1.0 mL · min^- 1 with gradient elution. The column temperature was 25 ℃; the ELSD drift tube temperature was 80 ℃ and the gas fl ow was 1.8 L · min^- 1. Results Good separation and linear range were obtained. The average recoveries of fructose, glucose and sucrose were 96.7%（RSD = 0.70%）, 96.6%（RSD = 1.3%）, and 98.61%（RSD = 2.9%）, respectively. Conclusion The established method is simple, reliable and accurate. It can be used to determine the saccharide components in Kudiezi injection, and provide theoretical basis for its quality control.