《中国药典》2020年版硝酸甘油片质量标准增修订建议
Updates and amendments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020
李梓莹 1杨梅 1李玮玲 1伍良涌 1董顺玲1
作者信息
摘要
目的:针对《中国药典》2020年版二部硝酸甘油片质量标准中色谱条件不能有效分离4个已知杂质及游离硝酸根与辅料未能分离的问题,对该质量标准提出增修订建议.方法:采用高效液相色谱法,通过梯度洗脱的方法检查有关物质,同时通过另一色谱系统检查游离硝酸根的量.结果:按改进方法进行有关物质及游离硝酸根检查,11批硝酸甘油片的1-硝酸甘油及2-硝酸甘油均小于0.1％,1,2-二硝酸甘油及1,3-二硝酸甘油均小于0.5％,杂质总量均不过2.4％,游离硝酸根均不过6.3％.结论:本改进方法操作简单,实验结果准确可靠,为《中国药典》2020年版二部中硝酸甘油片质量标准增修订提供了参考.
Abstract
Objective:To propose updates and amendments for the nitroglycerin tablets quality in the Chinese phar-macopoeia 2020 due to the failure of effective separation of 4 known impurities and nonseparation of free nitrate ion and excipients.Methods:Related substances were analyzed using gradient elution by HPLC,and free nitrate ion was determined on SAX column by different HPLC method.Results:Using the improved method to test the related substances and free nitrate ion of nitroglycerin tablets,the content of the maximum individual impurity were not more than 0.5％,the total content was not more than 2.4％and the content of free nitrate ion was not more than 6.3％.Conclusion:The improved method is accurate and feasible.It provided a reference for the updates and amend-ments of the quality standard of nitroglycerin tablets in the Chinese Pharmacopoeia 2020.
关键词
硝酸甘油/高效液相色谱法/游离硝酸根/有关物质/质量标准增修订Key words
nitroglycerin/HPLC/free nitrate ion/related substance/updates and amendments of quality standard引用本文复制引用
基金项目
国家药典委员会标准修订研究课题(2020H028)
广州市市场监督管理局科技项目(2022jk34)
出版年
2024
NETL
NSTL
万方数据