Guan Jia, Bi Zhi-ming, Li Ping
Department of Pharmacognosy, China Pharmaceutical University, Nanjing 210038, China.
Zhongguo Zhong Yao Za Zhi. 2006 May;31(10):807-9.
To develop an HPLC method for fingerprint determination of the astragalosides injection.
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).
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.
The method was reliable and simple which could be used for quality control of the injection.
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。
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。
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。
该方法可靠且简便，可用于该注射液的质量控制。
