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头孢唑肟钠混合降解杂质对照物的研究与应用 预览

Development and application of reference materials containing mixed degradation products of ceftizoxime sodium
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摘要 目的:研究制备头孢唑肟钠混合降解杂质对照物并应用于有关物质及含量测定系统适用性检查。方法:采用控速强制降解试验,获得目标混合降解杂质;选择适宜参数范围的色谱柱分析混合杂质对照物,选择保留时间合适且所有杂质都得到有效分离的色谱图作为标准谱图;采用柱切换LC-MS方法结合头孢唑肟钠降解规律鉴定各杂质结构。结果:混合降解杂质对照物中共检出7个杂质,各杂质可在6根色谱柱中有效分离。结论:头孢唑肟钠混合降解杂质对照物的研究与应用是评价色谱系统的分离能力的有效手段,便于快速分析杂质来源。 Objective:Reference materials containing mixed degradation products of ceftizoxime sodium were developed and applied to system suitability test for system suitability test. Methods: The target impurity were ob- tained by controlled stress testing; Establish a more reasonable evaluation standard for system suitability test,then the standard chromatogram was determined. Each major component was identi?ed by column switching LC-MS technique combining with the degradation mechanism of ceftizoxime sodium;Results: Seven impurities are deter- mined in reference materials containing mixed degradation products, the impurities can be separated effectivly in six chromatographic column.Conclusion: Development and application of reference materials containing mixed degradation products of ceftizoxime sodium are an effective way for evaluation of chromatographic system and rapid identification of impurities.
作者 于佳 张一竹 李委佳 杨利红 刘雅琴 YU Jia1, ZHANG Yi-zhu2, LI Wei-jia3, YANG Li-hong1, LIU Ya-qin1 ( 1.Heilongjiang Institute for Food and Drug Control, Harbin 150088,China;2.National Institutes for Food and Drug Control, Beijing 100050, China;3.The Second Affiliated Hospital of Harbin Medical University, Harbin 150086 , China)
出处 《化学工程师》 CAS 2018年第2期8-10,20共4页 Chemical Engineer
基金 哈尔滨市应用技术研究与开发项目一科技创新人才(No.2015RQQYJ002)
关键词 头孢唑肟钠 混合降解杂质 对照物 ceftizoxime sodium mixed degradation products reference materials
作者简介 于佳(1983-),女,硕士,副主任药师,研究方向:药物分析和药品质量控制。;通讯作者:刘雅琴(1964-)女,学士,主任医师,研究方向:药物分析和药品质量控制。
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