[黄芪甲苷注射液的高效液相色谱-蒸发光散射检测法指纹图谱研究]
[Study on fingerprints of astragalosides injection by HPLC-ELSD].
作者信息
Guan Jia, Bi Zhi-ming, Li Ping
机构信息
Department of Pharmacognosy, China Pharmaceutical University, Nanjing 210038, China.
出版信息
Zhongguo Zhong Yao Za Zhi. 2006 May;31(10):807-9.
OBJECTIVE
To develop an HPLC method for fingerprint determination of the astragalosides injection.
METHOD
Analyses were carried out at 25 degrees C on a Zorbax SB-C18 column (4.6 mm x 250 mm,5 microm). Mobile phase A was water, and B was acetonitrile. The analysis followed a linear gradient program. Initial conditions were 15% B; 0 to approximately 65 min, changed to 60% B. The flow rate was 0.8 mL x min(-1). The drift tube temparature of the ELSD was 105 degrees C, and gas flowrate was 2.7 L x 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.
目的
建立一种用于黄芪总苷注射液指纹图谱测定的高效液相色谱法。
方法
在25℃下于Zorbax SB - C18柱（4.6 mm×250 mm，5μm）上进行分析。流动相A为水，流动相B为乙腈。分析采用线性梯度程序。初始条件为15% B；0至约65分钟，变为60% B。流速为0.8 mL·min⁻¹。蒸发光散射检测器（ELSD）的漂移管温度为105℃，气体流速为2.7 L·min⁻¹。
结果
药材、提取物和注射液指纹图谱中共有峰相对保留时间的相对标准偏差（RSD）小于0.1%，10批样品之间具有良好的相似度。
结论
该方法可靠且简便，可用于该注射液的质量控制。
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