HPLC-MS/MS法分析孟鲁司特钠颗粒中的有关物质

王英新; 刘玲; 李树英; 兰颐; 聂磊

doi:10.11665/j.issn.1000-5048.20190309

HPLC-MS/MS法分析孟鲁司特钠颗粒中的有关物质

王英新^1,2,
刘玲²,
李树英²,
兰颐²,
聂磊¹

1.
山东大学药学院
2.
山东达因海洋生物制药股份有限公司

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出版历程
- 刊出日期: 2019-06-24

Analysis of related substances in montelukast sodium granules by HPLC-MS/MS

摘要

摘要: 采用HPLC-MS/MS联用技术研究孟鲁司特钠颗粒的有关物质种类及来源途径。利用HPLC-MS/MS方法对市售孟鲁司特钠颗粒剂(顺尔宁^®；，规格4 mg)的有关物质进行分离与质谱解析，再根据孟鲁司特钠合成工艺、降解途径及相关文献，确定各有关物质结构及来源。研究结果显示，市售孟鲁司特钠颗粒中共检测到7个杂质，同时基于MS/MS技术并结合相关文献对有关物质 1 ~ 7 的来源和结构进行了确认，其中有关物质 7 (孟鲁司特喹啉环氮氧化物)未见相关文献报道。通过对孟鲁司特钠颗粒有关物质和来源途径的研究，将对相关制剂研究和质量控制提供参考与指导。
- 孟鲁司特钠 /
- 孟鲁司特钠颗粒 /
- 顺尔宁 /
- 有关物质 /
- HPLC-MS/MS
Abstract: The aim of this paper was to study the species and sources of related substances in montelukast sodium granules based on HPLC-MS/MS. The related substances of the already marketed montelukast sodium granules(Singulair, 4 mg)were firstly separated and identified by HPLC-MS/MS method, and their chemical structures and sources were confirmed according to the pulished synthesis process and degradation studies. The results revealed that there were 7 related substances, whose chemical structures and sources were confirmed based on the MS/MS technique and the related literature. Impurity 7 , montelukast quinoline ring oxynitride, had not been reported. This study systematically analyzed the related substances in the commercical product, which provides useful information for the development and quality control of the product.
- montelukast sodium /
- montelukast sodium granules /
- singulair /
- related substances /
- HPLC-MS/MS

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参考文献(9)

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