HPLC-MS/MS法分析孟鲁司特钠颗粒中的有关物质

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

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4mg)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。

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.