中国标准化Issue(21)：240-244,5.DOI:10.3969/j.issn.1002-5944.2025.21.034
关于药用辅料苯扎氯铵含量测定方法的探讨
Discussions on the Determination Methods of Benzalkonium Chloride Content for Pharmaceutical Excipients
石蓉 1蒋贇 1赵勇 1郑金凤 1刘雁鸣 1张悦1
作者信息
- 1. 湖南省药品检验检测研究院/国家药品监督管理局药用辅料工程技术研究重点实验室
- 折叠
摘要
Abstract
By comparing three methods for the content determination of benzalkonium chloride and analyzing the advantages and disadvantages of each method,the most convenient and feasible method for the content determination of benzalkonium chloride was discussed,so as to provide reference for the quality control and standards development of benzalkonium chloride used as a pharmaceutical excipient.The high performance liquid chromatography(HPLC),potassium iodate titration,and sodium tetraphenylborate titration methods were used to determine the content of benzalkonium chloride.The potassium iodate titration and sodium tetraphenylborate titration methods were calculated based on fixed and modified titration degree,and the results were compared.Compared with chemical titration methods,the contents of samples determined by HPLC were higher in different degrees.No significant difference was found from the content results of samples between the sodium tetraphenylborate titration method and the potassium iodate titration method,but the parallelism of results from the sodium tetraphenylborate titration method was much better than the potassium iodate titration method,the alignment deviation of which was less than 1%.Compared with the calculation results based on fixed titration degree,the results calculated based on modified titration degree could reflect the actual content more accurately.Among the three methods,the results of HPLC were higher than those of chemical titration,and sodium tetraphenylboride titration was preferred to calculate the content based on the modified titration degree.关键词
苯扎氯铵/含量测定/高效液相色谱法/碘酸钾滴定法/四苯硼钠滴定法Key words
benzalkonium chloride/content determination/high performance liquid chromatography/potassium iodate titration/sodium tetraphenylborate titration引用本文复制引用
石蓉,蒋贇,赵勇,郑金凤,刘雁鸣,张悦..关于药用辅料苯扎氯铵含量测定方法的探讨[J].中国标准化,2025,(21):240-244,5.
