利奈唑胺主要降解产物的结构鉴定

Structure identification of the main degradation products of linezolid

目的:对利奈唑胺主要降解产物的结构进行鉴定。方法:对利奈唑胺原料药进行强力破坏试验,采用高效液相色谱法对降解产物进行分析,应用LC-MS对3个主要的降解产物进行结构鉴定,并利用合成所得杂质对照品对降解产物的结构进行了确证。结果:3个主要的降解产物分别为利奈唑胺的全水解物、开环水解物以及氨基物。结论:利奈唑胺在碱性和酸性条件下的降解产物不相同。在碱性条件下的降解产物主要为全水解物和开环水解物,而在酸性条件下的降解产物主要为氨基物。

Objective： To identify the structure of the main degradation products of linezolid.Methods： Stress destruction testing was applied to the crude drug of linezolid,with an HPLC method to analyze the degradation products.The three main degradation products were identified by LC-MS,and the structure of them were confirmed through comparison with synthetic impurities.Results： Three main degradation products are the full hydrolysate,the ring-opening hydrolysate and the amido substance of linezolid.Conclusion： The alkaline hydrolysis products of linezolid are different from the acid hydrolysis product.The main alkaline hydrolysis products are the full hydrolysate and the ring-opening hydrolysate,while the acid hydrolysis product is the amido substance.