高效液相色谱法测定三层共挤输液用管中芥酸酰胺含量  

Content Determination of Erucamide in Three-Layer Co-Extrusion Infusion Tube by HPLC

作　　者：李莎 杨柳 吴红洋 蒲道俊 余春梅 范能全 LI Sha;YANG Liu;WU Hongyang;PU Daojun;YU Chunmei;FAN Nengquan(Chongqing Institute for Food and Drug Control,Chongqing,China 401121;Southwest Pharmaceutical Co.,Ltd.,Chongqing,China 400038)

机构地区：[1]重庆市食品药品检验检测研究院,重庆401121 [2]西南药业股份有限公司,重庆400038

出　　处：《中国药业》2021年第17期70-72,共3页China Pharmaceuticals

基　　金：重庆市科研机构绩效激励引导专项项目[cstc2019jxjl130040]。

摘　　要：目的建立测定三层共挤输液用管中芥酸酰胺含量的高效液相色谱法。方法色谱柱为Agilent Zorbax SB-C18柱(250 mm×4.6 mm,5μm),流动相为乙腈,流速为1.0 m L/min,检测波长为200 nm,柱温为60℃,进样量为10μL。结果芥酸酰胺的质量浓度在5.12~307.14μg/m L范围内与峰面积线性关系良好(R^(2)=1.000,n=7);检测限和定量限分别为0.16μg/m L和0.50μg/m L;精密度、稳定性、重复性试验的结果均符合要求;平均加样回收率为94.73%,RSD为1.38%(n=9)。结论该方法操作简便,结果准确,重复性好,可用于三层共挤输液用管中芥酸酰胺的含量测定。Objective To establish a high-performance liquid chromatography(HPLC)method for the content determination of erucamide in the three-layer coextrusion infusion tube.Methods The chromatographic column was Agilent Zorbax SB-C18 column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile,the flow rate was 1.0 m L/min,the detection wavelength was 200 nm,the column temperature was 60℃,and the injection volume was 10μL.Results The linear range of erucamide was 5.12-307.14μg/m L(R^(2)=1.000,n=7).The limit of detection(LOD)and limit of quantitation(LOQ)of erucamide were 0.16μg/m L and 0.50μg/m L,respectively.The results of the precision,stability and repeatability tests could meet the requirements.The average recovery of erucamide was 94.73%with RSD of 1.38%(n=9).Conclusion The method was simple and accurate with good repeatability,which can be used for the content determination of erucamide in the three-layer co-extrusion infusion tube.

关 键 词：高效液相色谱法 三层共挤输液用管 芥酸酰胺 含量测定 

分 类 号：R955[医药卫生—药学]