高效液相色谱法同时测定输液器中7种抗氧剂的迁移量  

Simultaneous Determination of Migration of Seven Antioxidants from Infusion Set by HPLC

作　　者：韩海燕 蒲道俊 吴红洋 余春梅 范能全 HAN Haiyan;PU Daojun;WU Hongyang;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23期58-61,共4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：目的建立同时测定输液器中7种抗氧剂[抗氧剂1310,1010,330,1076,168及2,4-二叔丁基苯酚(2,4-DTBP)、抗氧剂2,6-二叔丁基对甲酚(BHT)]在盐酸莫西沙星氯化钠注射液中迁移量的高效液相色谱(HPLC)法。方法色谱柱为Agilent 5 TC-C_(18)(2)柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%乙酸溶液(梯度洗脱),流速为1.0 m L/min,检测波长为228 nm,柱温为35℃,进样量为20μL。结果抗氧剂1310,1010,330,1076,168,BHT,2,4-DTBP的质量浓度均在0.5~20.0μg/m L范围内与峰面积线性关系良好(R^(2)≥0.9990);检测限分别为0.10,0.10,0.10,0.20,0.10,0.10,0.10μg/m L;精密度、稳定性、重复性试验的RSD均低于15%(n=6);平均回收率分别为97.25%,97.70%,97.41%,98.49%,95.89%,96.00%,104.39%,RSD分别为4.81%,3.94%,3.44%,5.13%,7.96%,12.25%,11.91%(n=9);抗氧剂2,4-DTBP和BHT在0,60,90,120 min时的迁移量均不超过0.04μg/m L,抗氧剂1310,330,1010,1076,168均未检测到。结论该方法操作简便,灵敏度高,适用性好,稳定性和重复性均较好,可用于测定输液器中抗氧剂在盐酸莫西沙星氯化钠注射液中的迁移量。Objective To establish a high-performance liquid chromatography(HPLC)for the simultaneous determination of the migra-tion of seven antioxidants[antioxidants 1310,1010,330,1076,168,2,4-di-tert-butyl phenol(2,4-DTBP),and antioxidant 2,6-di-tert-butyl-4-methylphenol(BHT)]from infusion set to Moxifloxacin Hydrochloride Sodium Chloride Injection.Methods The chromatographic column was Agilent 5 TC-C_(18)(2)column(250 mm×4.6 mm,5μm),the mobile phase was methanol-0.1%acetic acid solution(gradient elution),the flow rate was 1.0 m L/min,the detection wavelength was 228 nm,the column temperature was 35℃,and the injection volume was 20μL.Results The antioxidants 1310,1010,330,1076,168,BHT,2,4-DTBP showed good linear relationship in range of 0.5-20.0μg/m L(R^(2)≥0.9990),and their limits of detection were 0.10,0.10,0.10,0.20,0.10,0.10 and 0.10μg/m L,respectively.The RSDs of precision,stability and repeatability tests were less than 15%(n=6).The average recoveries of antioxidants 1310,1010,330,1076,168,BHT,2,4-DTBP were 97.25%,97.70%,97.41%,98.49%,95.89%,96.00%and 104.39%with RSDs of 4.81%,3.94%,3.44%,5.13%,7.96%,12.25%and 11.91%(n=9),respectively.The migration of antioxi-dants 2,4-DTBP and BHT at 0,60,90 and 120 min was not more than 0.04μg/m L,antioxidants 1310,3301010,1076 and 168 were not detected.Conclusion The method has the advantages of simple operation,high sensitivity,good applicability,stability and repeatability,which can be used for the determination of the migration of antioxidants from infusion set to Moxifloxacin Hydrochloride Sodium Chloride Injection.

关 键 词：高效液相色谱法 输液器 盐酸莫西沙星氯化钠注射液 抗氧剂 迁移量 

分 类 号：R917[医药卫生—药物分析学] R927.1[医药卫生—药学]