摘要
目的:建立高效液相色谱-蒸发光散射检测法测定银杏达莫注射液中吐温-80的含量。方法:采用HPLC-ELSD法,G2000SWXL凝胶色谱柱,柱温为30℃;以乙腈-0.02 mol/L醋酸铵(体积比10∶90)为流动相;漂移管温度:103℃;氮气流速2.3 mL/min。结果:吐温80在111.1~2221.6μg/mL的范围内呈良好的线性关系(Y=1.4582X+2.3569,r=0.9996);方法重复性良好(RSD=0.2%);方法回收率为103.1%,RSD为1.5%(n=9);样品10 h内稳定性良好(RSD=0.6%)。结论:该方法用于测定银杏达莫注射液中吐温80的含量,专属性强,准确度较高,样品稳定性良好,为注射剂中吐温-80的含量测定提供参考,对保证注射剂的安全性具有实际意义。
Objective:To establish a high performance liquid chromatographer-evaporative light scattering detection method for the determination of Tween-80 in Ginkgo Damo injection.Methods:The chromatography was performed on G2000SWXL gel column by HPLC-ELSD method,and the column temperature was 30℃.Acetonitrile-0.02 mol/L ammonium acetate(volume ratio 10∶90)was used as mobile phase.Drift tube temperature:103℃;The nitrogen flow rate is 2.3 mL/min.Results:Tween 80 showed a good linear relationship in the range of 111.1~2221.6μg/mL(Y=1.4582X+2.3569,r=0.9996).The method had good repeatability(RSD=0.2%).Methods recovery rate was 103.1%,RSD was 1.5%(n=9).The sample was stable within 10 h(RSD=0.6%).Conclusion:This method has strong specificity,high accuracy and good sample stability for the determination of Tween-80 in Ginkgo Damo injection.It provides reference for the determination of Tween-80 in injection and has practical significance for ensuring the safety of injection.
作者
田甜
王璐
祝晶
漆欣筑
TIAN Tian;WANG Lu;ZHU Jing;QI Xinzhu(Guizhou Institute for Food and Drug Inspection,Guiyang 550081,China)
出处
《山东化工》
2025年第2期213-215,共3页
Shandong Chemical Industry
基金
贵州省2022年度省级药品探索性研究课题。
