摘要
目的:建立黄芪皂苷类成分注射液(包括药材、中间体及注射液制剂)的HPIE-ELSD指纹图谱质量控制方法。方法:Agilent Zorbax SB-C18柱,流动相为A水-B乙腈,二元梯度洗脱:15%~60%B(0—65min),流速0.8mL·mi^-1,蒸发光散射检测器,漂移管温度105℃,载气流速2.7L·min^-1。结果:药材、中间体、注射液制剂中标定的各共有峰相对保留时间的RSD值均小于1.0%,单峰面积大于或等于10%峰的峰面积比值也比较稳定,三者的图谱间具有很好的相关性,10批样品间具有很高的相似度。结论:本方法可作为黄芪皂苷注射液质量控制的依据。
Objective: To develop an HPLC method for fingerprint determination of the astragalosides injection. Method: Analyses were carried out at 25℃ on a Zorbax SB-C18 column (4.6 mm× 250 mm,5 μm). Mobile phase A was water, and B was acetonitrile. The analysis followed a linear gradient program. Initial conditions were 15% B; 0 ~ 65 rain, changed to 60% B. The flow rate was 0.8 mL·min^-1 The drift tube temparature of the ELSD was 105℃, and gas flowrate was 2.7 L·min^-1. Result: The RSD of relative retention time of the common peaks in the plant material, the extract and the injection fingerprints was less than 0. 1%, and there was good similarity among 10 batches of samples. Condusion: The method was reliable and simple which could be used for quality control of the injection.
出处
《中国中药杂志》
CAS
CSCD
北大核心
2006年第10期807-809,共3页
China Journal of Chinese Materia Medica
基金
国家自然科学基金重大资助项目(90209045)
关键词
指纹图谱
黄芪皂苷
注射液
HPLG fingerprint
astragaloside
injection
作者简介
[通讯作者]李萍.Tel:(025)85322256,E-mail:lipingli@publicl.ptt.js.cn