《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

作　　者：李梓莹 杨梅 李玮玲[1] 伍良涌[1] 董顺玲[1] LI Ziying;YANG Mei;LI Weiling;WU Liangyong;DONG Shunling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药品标准》2024年第1期18-24,共7页Drug Standards of China

基　　金：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)。

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。Objective:To propose updates and amendments for the nitroglycerin tablets quality in the Chinese pharmacopoeia 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 amendments 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 

分 类 号：R921.2[医药卫生—药学]