凝胶色谱-蒸发光散射检测法检测中药注射剂中吐温80的含量

目的:运用凝胶色谱-蒸发光散射检测法(GPC-ELSD)建立一种中药注射剂中吐温80检测的通用方法。方法:采用TSK gel G2000SWXL(8.7 mm×30.0 cm)色谱柱,柱温30℃;以0.02 mol·L^-1醋酸铵溶液-乙腈(90:10)为流动相,流速0.6 mL·min^-1,进样量20 μL;采用Alltech ELSD2000ES检测器,漂移管温度110℃,氮气流速2.3 L·min^-1。结果:吐温80浓度在0.5~3.1 mg·mL^-1范围内线性关系良好(r=0.9961);吐温80的回收率范围在93.8%~99.2%之间(n=5), RSD范围在0.8%~2.8%之间(n=5);检出限为1.27 μg。用该方法检测了19种78批中药注射剂,吐温80含量在0~20 mg·mL^-1。结论:该检测方法灵敏、简便,专属性强,重复性好,能够满足吐温80的含量测定。

Objective:To establish a general method for the detection of Tween 80 content in traditional Chinese medicine injections by gel permeation chromatography-evaportive light scattering detector(GPC-ELSD). Methods:TSK gel G2000SWXL column(8.7 mm×30.0 cm) was adopted;the column temperature was controlled at 30℃;the mobile phase was a mixture of 0.02 mol·L^-1 ammonium acetate-acetonitrile(90:10) with a flow rate at 0.6 mL·min^-1;the injection volume was 20 μL.A light-scattering detector(Alltech ELSD 2000ES) was adopted;the temperature of drift tube for EISD was 110℃ and the flow rate of gas was 2.3 L·min^-1. Results:In the range of 0.5-3.1 mg·mL^-1,the concentrations of Tween 80 showed a good linear relationship with the peak area(r=0.9961);The recoveries(n=5) ranged from 93.8% to 99.2%,RSD(n=5) values from 0.8% to 2.8%,and LOD values was 1.27 μg.The established method was applied to detect 78 batches(19 kinds) of traditional Chinese medicine injections,the content of Tween 80 was between 0 mg·mL^-1 and 20 mg·mL^-1,which was consistent with the labeled amount. Conclusions:The method is sensitive,convenient,specific,reproducible and suitable for the detection of Tween 80.