摘要
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0.6mL.min-1,进样量20μL;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1.27μg。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）. Meth- ods： 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 adopt- ed;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 p^g. 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 con- sistent with the labeled amount. Conclusion： The method is sensitive, convenient, specific, reproducible and suit- able for the detection of Tween 80.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2012年第9期1686-1689,1693,共5页
Chinese Journal of Pharmaceutical Analysis
