HPLC法同时测定直立式聚丙烯输液袋中抗氧剂1010与抗氧剂168的含量  

HPLC determination of antioxidant 1010 and antioxidant 168 in vertical polypropylene infusion bags

作　　者：鹿广玲 田鑫 王兰周 张建永 Lu Guangling;Tian Xin;Wang Lanzhou;Zhang Jianyong(School of Pharmacy,Zunyi Medical University,Zunyi Guizhou 563099,China;Key Laboratory of Basic Pharmacology of Ministry of Education and Joint International Research Laboratory of Ethnomedicine of Ministry of Education,Zunyi Medical University,Zunyi Guizhou 563099,China;Guizhou Tiandi Pharmaceutical Company Limited,Xingyi Guizhou 562400,China)

机构地区：[1]遵义医科大学药学院,贵州遵义563099 [2]遵义医科大学基础药理教育部重点实验室暨特色民族药教育部国际合作联合实验室,贵州遵义563099 [3]贵州天地药业有限责任公司,贵州兴义562400

出　　处：《遵义医科大学学报》2022年第6期782-785,共4页Journal of Zunyi Medical University

基　　金：贵州省教育厅科技拔尖人才支持项目(NO:黔教合KY字[2017]078);遵义市优秀青年科技创新人才培养项目(NO:遵优青科[2021]3)。

摘　　要：目的 建立药品包装材料直立式聚丙烯输液袋中抗氧剂1010、抗氧剂168的高效液相色谱(HPLC)含量测定方法。方法 采用Welch XB-C_(18)色谱柱(4.6 mm×250 mm,5μm);流动相为乙腈-四氢呋喃-水(63∶30∶7);流速为1.5 mL/min;柱温为30℃;检测波长为280 nm;进样体积为20μL。结果 本研究建立的方法,抗氧剂1010、抗氧剂168分别在2.362~283.416μg/mL和4.724~283.416μg/mL范围内线性关系良好,相关系数r均为0.999 9。测定方法中抗氧剂1010、抗氧剂168的回收率分别为103.1%~109.2%(RSD:1.73%~3.45%),97.8%~104.8%(RSD:2.16%~3.53%)。结论 该方法操作简单,结果准确,重复性好,可用于直立式聚丙烯输液袋中抗氧剂1010、抗氧剂168的含量测定及质量控制。Objective To establish a method for the determination of antioxidant 1010 and antioxidant 168 in vertical polypropylene infusion bags by HPLC.Methods The Welch XB-C_(18 )analytical column(4.6 mm×250 mm,5 μm) was adopted with the mobile phase of acetonitrile-tetrahydrofuran-water(63∶30∶7) at a flow rate of 1.5 mL/min.The column temperature was set as 30 ℃.The detection wavelength was 280 nm.The injection volume was 20 μL.Results The method had a good linear relationship within the range of 2.362~283.416 μg/mL and 4.724~283.416 μg/mL for antioxidant 1010 and antioxidant 168,respectively,with the correlation coefficients of 0.999 9.The average recoveries of the two ingredients were 103.1%~109.2%(RSD:1.73%~3.45%)and 97.8%~104.8%(RSD:2.16%~3.53%),respectively.Conclusion This method is rapid,convenient and accurate,so it could be used for investigating the contents of antioxidant 1010 and antioxidant 168 in vertical polypropylene in fusion bags and quality control.

关 键 词：高效液相色谱法 直立式聚丙烯输液袋 抗氧剂 质量控制 

分 类 号：R917[医药卫生—药物分析学]