HPLC法测定雾化吸入用聚乙烯塑料安瓿中抗氧剂的含量研究  

HPLC method to determine the content of antioxidants in PE ampoules for inhalation solution

作　　者：邵奇 周雅茹 孙宁云 毛毅斌 Shao Qi;Zhou Yaru;Sun Ningyun;Mao Yibin(SPH Sine Pharmaceutical Laboratories Co.,Ltd.,Shanghai 201206,China)

机构地区：[1]上海上药信谊药厂有限公司,上海201206

出　　处：《江苏科技信息》2022年第34期66-70,共5页Jiangsu Science and Technology Information

基　　金：上海市2018年度“科技创新行动计划”产学研医合作领域项目,项目名称:吸入创新药物研发与儿童吸入药物临床评价,项目编号:18DZ1910600。

摘　　要：文章采用HPLC法建立雾化吸入用聚乙烯塑料安瓿中7种抗氧剂的迁移及浸出水平的检测方法,并进行分析方法验证,在完成验证的基础上对迁移物和浸出物进行检测。结果表明:该方法测定的7种抗氧剂具有良好的线性关系,R≥0.99,检出限(LOD)和定量限(LOQ)分别为0.0024和0.0079μg/mL。参考相容性指导原则考察了3种模拟提取条件50%乙醇水溶液、pH 3.0磷酸盐缓冲溶液、正己烷下的迁移水平。该方法回收率在92.7%~95.0%,RSD在1.2%~2.7%。利用该方法可以有效完成7种抗氧剂的分析,并能够检测硫酸沙丁胺醇雾化吸入溶液制剂中的浸出物水平,检测结果均未检出相关抗氧剂。结果表明,该方法准确、稳定、检测灵敏度高。In this paper,the HPLC method was used to establish the detection method for migration and leaching level of seven antioxidants in polyethylene plastic ampoules for atomization inhalation,and the analytical method was verified.On the basis of the verification,the migration and leaching were detected.The results show that seven antioxidants determined by this method had a good linear relationship,R≥0.99,LOD and LOQ were 0.0024 and 0.0079μg/mL,respectively.Reference compatibility guidelines examined the leachable levels of three simulated extraction conditions under 50%aqueous ethanol solution,pH 3.0 phosphate buffer solution,and n-hexane.The recovery rate of this method is between 92.7%~95.0%,and the RSD is between 1.2%~2.7%.The analysis of seven kinds of antioxidants can be effectively completed by using this method,and can detect the level of extractable in the formulation of salbutamol sulfate inhalation solution.None of the test results detected any related antioxidants.The results show that the proposed method is accurate,stable and has high detection sensitivity.

关 键 词：聚乙烯塑料安瓿 抗氧剂 吸入溶液 浸出物与提取物 

分 类 号：R944[医药卫生—药剂学]