| 盐酸艾司洛尔注射液中杂质的分离、合成与结构鉴定 |
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| 引用本文： | 肖小武,程奇珍,熊蔚,李平,罗跃华.盐酸艾司洛尔注射液中杂质的分离、合成与结构鉴定[J].药物分析杂志,2011(1). |
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| 作者姓名： | 肖小武 程奇珍 熊蔚 李平 罗跃华 |
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| 作者单位： | 南昌大学药学院;江西省食品药品检验所;江西省药品审评中心; |
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| 基金项目： | 国家“十一五”科技支撑项目(项目编号:2008BA155B00) |
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| 摘 要： | 目的:研究盐酸艾司洛尔注射液中杂质的结构和产生的原因。方法:采用制备高效液相色谱方法制备分离盐酸艾司洛尔注射液的杂质并采用IR、MS1、H-NMR、13C-NMR等方法进行结构鉴定;合成制备了此杂质并进行结构确证。结果:该杂质为4-{2-羟基-3-(1-甲基乙基)氨基]]丙氧基}苯丙酸盐酸盐,为盐酸艾司洛尔注射液在储藏过程的降解产物。结论:本研究可为盐酸艾司洛尔注射液质量评价提供依据。
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| 关 键 词： | 盐酸艾司洛尔注射液 杂质 分离 合成 结构鉴定 |
Separation,systhesis and identification of the impurity of esmolol hydrochloride injection |
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| XIAO Xiao-wu,CHENG Qi-zhen,XIONG Wei,LI Ping,LUO Yue-hua.Separation,systhesis and identification of the impurity of esmolol hydrochloride injection[J].Chinese Journal of Pharmaceutical Analysis,2011(1). |
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| Authors: | XIAO Xiao-wu CHENG Qi-zhen XIONG Wei LI Ping LUO Yue-hua |
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| Affiliation: | XIAO Xiao-wu1,2,CHENG Qi-zhen2,XIONG Wei2,LI Ping3,LUO Yue-hua1,2(1.The Pharmceutial Department of Nanchang University,Nanchang 330046,China,2.Jiangxi Institute for Drug and Food Control,Nanchang 330029,3.The Center for Drug Evaluation of Jiangxi Province,China) |
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| Abstract: | Objective:To identify the structure and source of the impurity of esmolol hydrochloride injection.Methods:The impurity of esmolol hydrochloride injection was separated by prep-HPLC,and its structure was identified by IR,MS,1H-NMR,13C-NMR;The impurity was synthesized and the structure was identified.Results:The impurity of esmolol hydrochloride injection is confirmed to be 4-{2-hydroxy-3-(1-methylethyl)amino]]propoxy} benzenepropanoic acid methyl ester hydrochloride;It is degradation product of the esmolol... |
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| Keywords: | esmolol hydrochloride injection impurity separation systhesis structure identification |
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