| 引用本文: | 贾雪冬,张婉,李卓伦,左莉华,周霖,孙志,杜书章.基于UHPLC-Q-Orbitrap HRMS的伊伐布雷定有关物质结构鉴定[J].中国现代应用药学,2022,39(15):1992-2000. |
| JIA Xuedong,ZHANG Wan,LI Zhuolun,ZUO Lihua,ZHOU Lin,SUN Zhi,DU Shuzhang.Structural Identification of Related Substances of Ivabradine Based on UHPLC-Q-Orbitrap HRMS[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(15):1992-2000. |
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| 基于UHPLC-Q-Orbitrap HRMS的伊伐布雷定有关物质结构鉴定 |
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贾雪冬1,2, 张婉1,2, 李卓伦1,2, 左莉华1,2, 周霖1,2, 孙志1,2, 杜书章1,2
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1.郑州大学第一附属医院药学部, 郑州 450052;2.河南省精准临床药学重点实验室, 郑州 450052
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| 摘要: |
| 目的 对伊伐布雷定片有关物质进行结构鉴定，为其工艺优化和质量控制提供依据。方法 利用超高效液相色谱-四级杆/静电场轨道阱高分辨质谱技术（UHPLC-Q-Orbitrap HRMS）检测伊伐布雷定片及其强制降解溶液中的有关物质，根据其精确分子量、碎片裂解规律和化学结构，推测有关物质的化学结构。结果 共发现了22种有关物质，鉴定了其可能的化学结构，并对其来源进行了归属。结论 UHPLC-Q-Orbitrap HRMS技术能有效地鉴定伊伐布雷定中的有关物质，对其生产工艺优化和质量控制具有重要意义。 |
| 关键词: 超高效液相色谱-四级杆/静电场轨道阱高分辨质谱技术 伊伐布雷定 有关物质 结构鉴定 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.15.012 |
| 分类号:R917 |
| 基金项目:河南省高等学校重点科研项目计划（19B350008） |
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| Structural Identification of Related Substances of Ivabradine Based on UHPLC-Q-Orbitrap HRMS |
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JIA Xuedong1,2, ZHANG Wan1,2, LI Zhuolun1,2, ZUO Lihua1,2, ZHOU Lin1,2, SUN Zhi1,2, DU Shuzhang1,2
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1.Department of Pharmacy, The First Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China;2.Henan Key Laboratory of Precision Clinical Pharmacy, Zhengzhou 450052, China
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| Abstract: |
| OBJECTIVE To identify the structure of related substances of ivabradine tablets and to provide basis for process optimization and quality control. METHODS Ultra high performance liquid chromatography-quadrupole/electrostatic field orbitrap high resolution mass spectrometry(UHPLC-Q-Orbitrap HRMS) was used to detect related substances of ivabradine tablets and their forced degradation solution. According to its precise molecular weight, fragmentation law and chemical structure to infer the structure of related substances. RESULTS A total of 22 related substances were discovered, their possible chemical structures were identified, and their sources were assigned. CONCLUSION UHPLC-Q-Orbitrap HRMS technology can effectively identify related substances of ivabradine, which is of great significance for its optimization of production process and quality control. |
| Key words: UHPLC-Q-Orbitrap HRMS ivabradine related substances structure identification |
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