利奈唑胺主要降解产物的结构鉴定
Structure identification of the main degradation products of linezolid
分类号:
出版年·卷·期(页码):2013,33 (8):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------
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。
-----英文摘要:---------------------------------------------------------------------------------------
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.
-----参考文献:---------------------------------------------------------------------------------------
1 DENG Xue-e(邓雪娥).Linezolid(利奈唑胺).Chin J New Drugs(中国新药杂志),2001,10(11):846
2 CUI Xiang-li(崔向丽),ZHAO Zhi-gang(赵志刚).Pharmacology and clinical evaluation of linezolid(新型唑烷酮类抗生素利奈唑胺). Chin J New Drugs(中国新药杂志),2008,17(6):530
3 NAN Guang-ri(南光日),LI Dong(李冬).Clinical application of linezolid(利奈唑胺临床应用分析).Prac Pharm Clin Rem(实用药物与临床),2009,12(6):403
4 Hadden CE,Bowman PB,Duholke WH,et al.A long rang 15N-NMR study of the oxazolidinone antibiotic Zyvox and the major thermal degradation products.J Heterocyclic Chem,2000,37:1623
5 Belawy LI.Stability-indicating methods for the determination of linezolid in the presence of its alkaline-induced degradation products.Talanta,2003,60(5):945
6 Agrawal H,Mahadik KR,Paradkar AR,et al.Stability indicating HPTLC determination of linezolid as bulk drug and in pharmaceutical dosage form.Drug Dev Ind Pharm,2003,29(10):1119
7 Lopes C,Salgado H.Development of a validated stability indicating LC assay and stress degradation studies of linezolid in tablets.Chromatographia,2009,69:129
8 Mohapatra S,Annapurna M,Ravi Kumar B,et al.Validated stability indicating RP-HPLC method for the estimation of linezolid in a pharmaceutical dosage form.J Liq Chromatogr R T,2011,34:2185
9 Krishna Reddy KV,Mahender Rao S,Om Reddy G,et al.Isolation and characterization of process-related impurities in linezolid. J Pharm Biomed Anal,2002,30(3):635
欢迎阅读《药物分析杂志》!您是该文第 2505位读者!