中国中药杂志

2014, v.39(15) 2915-2917

[打印本页] [关闭]
本期目录(Current Issue) | 过刊浏览(Past Issue) | 高级检索(Advanced Search)

高效凝胶色谱串联蒸发光散射检测器测定热毒宁注射液中聚山梨酯80的含量
Determination of polysorbate 80 in Reduning injection by HGPC-ELSD

沈娟;张桥;李家春;毕宇安;王振中;萧伟;
SHEN Juan;ZHANG Qiao;LI Jia-chun;BI Yu-an;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Parmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

摘要(Abstract):

目的:采用高效凝胶色谱-蒸发光散射法(HGPC-ELSD),建立热毒宁注射液中聚山梨酯80的含量测定方法,控制热毒宁注射液中聚山梨酯80的质量。方法:采用TOSH TSK-GEL G4000PWxl(7.8 mm×300 mm,10μm)色谱柱,以水为流动相,流速0.7 mL·min-1,柱温30℃;蒸发光检测器,漂移管温度55℃,载气为氮气,流量2.0 L·min-1,增益1.0。结果:聚山梨酯80质量浓度在1.01~15.20 g·L-1线性关系良好(R2=0.999 3);方法回收率为98.10%(RSD 2.0%)。结论:该方法简单、快速,重复性好,适用于热毒宁注射液中聚山梨酯80的测定。
Objective:To establish the method for determining polysorbate 80 in Reduning injection by HPLC-ELSD,and to control the mass of polysorbate 80 in Reduning injection.Method:It was performed by HGPC-ELSD with TOSHTSK-GEL G4000PWxl(7.8 mm ×300 mm,10 μm).Water was used as mobile phase,the flow rate was 0.7 mL·min- 1,and the temperature was set at 30℃.The evaporated light scattering detector was adopted.The drift tube temperature was 55 ℃,and nitrogen was used as carrier gas,with the flow rate of 2.0 L·min- 1 and gain of 1.0.Result:The calibration curve showed good linearity of polysorbate 80 in the test range from 1.01 to 15.20 g·L- 1(r2= 0.999 3).The recovery rate was 98.10% with RSD of 2.0%.Conclusion:The method is simple,rapid,accurate and reliable and suitable for the determination of polysorbate 80 in Reduning injection.

关键词(KeyWords): 热毒宁注射液;聚山梨酯80;高效凝胶色谱-蒸发光散射法;质量控制
Reduning injection;polysorbate 80;HGPC-ELSD;quality control

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2013ZX09402203)

作者(Author): 沈娟;张桥;李家春;毕宇安;王振中;萧伟;
SHEN Juan;ZHANG Qiao;LI Jia-chun;BI Yu-an;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Parmaceutical Co.,Ltd.;State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process;

Email:

DOI:

扩展功能
本文信息
服务与反馈
本文关键词相关文章
本文作者相关文章
中国知网
分享