硝酸甘油片有关物质的研究  

The research on related substances of nitroglycerin tablets

作　　者：赵艳秋[1] 汪甜 尹燕杰[1] 张昊天[1] ZHAO Yanqiu;WANG Tian;YIN Yanjie;ZHANG Haotian(Harbin Food and Drug Inspection Center,Harbin 450001,China;Harbin Medical University,Harbin 450001,China)

机构地区：[1]哈尔滨市食品药品检验检测中心,哈尔滨150001 [2]哈尔滨医科大学,哈尔滨150001

出　　处：《中国药品标准》2020年第1期42-47,共6页Drug Standards of China

摘　　要：目的:利用液相色谱法、化学反应法、紫外光谱法及离子色谱法对硝酸甘油片中显著色谱峰进行分析,并确定该目标峰的组分及检测方法,帮助生产企业解决硝酸甘油片质量标准中有关物质杂质峰的判定和扣除问题。方法:结合《中国药典》2015年版硝酸甘油片有关物质检查法与JP 17版硝酸甘油片硝酸根离子限量检查法,对未知色谱峰定性,并通过离子色谱法进行定性及定量分析。结果:样品色谱图中2.4 min处色谱峰为硝酸根离子与辅料的重叠峰,且以硝酸根离子为主。结论:本研究采用多种方法验证了未知色谱峰的主要成分为硝酸根离子,为《中国药典》2015年版中硝酸甘油片质量标准的修订提供了参考。Objective:To develop HPLC method,chemical reaction,ultraviolet spectrum and IC method to determine the unknown chromatographic peaks in related substances of nitroglycerin tablets for the identification and deduction of impurity peaks in related substances.Methods:According to the methods of the related substances of nitroglycerin tablets in CHP(2015)and the free nitrate ion of nitroglycerin tablets in JP(17),qualitative analysis of the unknown chromatographic peaks,and then qualitative and quantitative analysis by the IC method.Results:The peaks which were obtained on the retention time of 2.4 min were judged as the overlapping chromatographic peaks of the nitrate ion and excipients.Conclusion:The research proved the principal component of unknown chromatographic peaks as the nitrate ion,the reference for revising the quality standards of nitroglycerin tablets in the 2015 edition of ChP was provided.

关 键 词：硝酸甘油片 有关物质 硝酸根离子 离子色谱 

分 类 号：R921.2[医药卫生—药学]