摘要
建立了LC-MS法分析醋酸兰瑞肽在氧化、高温、碱破坏条件下的强制降解样品,结果发现8个主要降解杂质。应用高分辨质谱(HRMS/MS)进行结构解析,同时探讨其降解机制,通过二硫苏糖醇(DTT)还原试验进一步验证杂质中单S及S-S-S结构,为该药物降解杂质谱及相关质量控制标准的研究提供参考,此外对这类以二硫桥方式成环的环肽药物的潜在降解杂质研究也提供了一定参考。
An LC-MS method was established to analyze the forced degradation samples of lanreotide acetate by oxidation,high temperature and alkali destructions.The results showed that eight degradation impurities were found.High resolution mass spectrometry(HRMS/MS) was used to analyze the structures of the main degraded impurities and the degradation mechanism was also discussed.The single S and S-S-S structures in impurities were further verified by the reduction test of dithiothreitol(DTT).This paper provides a reference for the studies of the degradation impurity profile and related quality control standards of this drug.In addition,it also provides some references for the study of potential degradation impurities of some cyclic peptides ringed by disulfide bridges.
作者
温学美
潘红娟
李悦
陆静
WEN Xuemei;PAN Hongjuan;LI Yue;LU Jing(State Key Labof New Drug&Pharmaceutical Process,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2022年第5期703-712,共10页
Chinese Journal of Pharmaceuticals
关键词
醋酸兰瑞肽
LC-MS
高分辨质谱
降解杂质
结构解析
lanreotide acetate
LC-MS
high resolution mass spectrometry
degradation impurity
structural analysis
