摘要
目的建立一种用于测定注射用益气复脉(冻干)中钠元素含量的方法。方法采用强阳离子交换色谱柱(SCX),以0.05 mol/L乙酸铵(乙酸调节p H至4.8)-乙腈(50:50)为流动相,体积流量为1.0 m L/min,柱温30℃,撞击器"关闭"模式,漂移管温度为90℃,压缩空气流量为2.5 L/min,检测器的增益值为1。结果钠元素在60~180μg/m L范围内线性良好(r=0.999 3);准确度试验(n=9)平均回收率为90.4%,RSD为1.8%;注射用益气复脉(冻干)中钠元素质量分数均值为0.48%(0.33%~0.55%)。结论所建立的方法简单可靠,可用于测定注射用益气复脉(冻干)中钠元素的含量测定。
Objective To establish an HPLC-ELSD method for the determination of the content of sodium element in Yiqi Fumai Lyophilized Injection. Methods The chromatographic separation was achieved on the strong cation exchange chromatography columns（SCX）. The mobile phase was 0.05 mol/L ammonium acetate solution（adjusted p H to 4.8 with acetic acid）-acetonitrile（50∶50）. The flow rate of the mobile phase was 1.0 m L/min. The column temperature was 30℃. The drift tube temperature was 90℃, the impactor was ＂OFF＂, the compressed air flow rate was 2.5 L/min and the gain of the detector was 1. Results Good linearity（r =0.9993）was observed in the standard curves of sodium element in the range of 60 —180 μg/m L. The accuracy experiments（n = 9）,the average recovery of sodium element was 90.4%, RSD was 1.8%. The content of sodium element in Yiqi Fumai Lyophilized Injection was 0.48%（range： 0.33%~0.55%）. Conclusion The method is simple and accurate, and is applicable for determining the content of sodium element in Yiqi Fumai Lyophilized Injection.
作者
李莉
李德坤
鞠爱春
LI Li;LI Dekun;JU Aiehun(Tianjin Tasly Pride Pharmaceutical Co., Ltd., Tianjin 300410, China;Key Laboratory of Safety Evaluation of Traditional Chinese Medicine Injections of Tianjin Enterprise, Tianjin 300410, China)
出处
《药物评价研究》
CAS
2018年第3期489-492,共4页
Drug Evaluation Research
基金
天津市中药注射剂关键技术校企协同创新实验室建设(17PTSYJC00090)
关键词
中药注射剂
注射用益气复脉(冻干)
钠元素
含量测定
过程控制
强阳离子交换色谱柱
HPLC-ELSD
蒸发光检测器
traditional Chinese medicine injection
Yiqi Fumai Lyophilized Injection
sodium element
content determination
process control
strong cation exchange chromatography columns
HPLC-ELSD
evaporative light scattering detector
