黄芪皂苷注射液指纹图谱的研究Study on fingerprints of astragalosides injection by HPLC-ELSD
管佳;毕志明;李萍;
GUAN Jia,BI Zhi-ming,LI Ping(Department of Pharmacognosy,China Pharmaceutical University,Nanjing 210038,China)
摘要(Abstract)：
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HPLC-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(0~65 min),流速0.8 mL.min-1,蒸发光散射检测器,漂移管温度105℃,载气流速2.7 L.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-C_(18) 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 min,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.Conclusion: The method was reliable and simple which could be used for quality control of the injection.
关键词(KeyWords)：
指纹图谱;黄芪皂苷;注射液
HPLC fingerprint;astragaloside;injection
基金项目(Foundation): 国家自然科学基金重大资助项目(90209045)
作者(Author):
管佳;毕志明;李萍;
GUAN Jia,BI Zhi-ming,LI Ping(Department of Pharmacognosy,China Pharmaceutical University,Nanjing 210038,China)
Email:
DOI:
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