气相色谱法检测泊洛沙姆188中环氧化物杂质  

Determination of epoxide impurity in Poloxamer188 by gas chromatography

作　　者：段梦茹 何东升 孙会敏[2] 熊晔蓉[1] 涂家生[1] DUAN Mengru;HE Dongsheng;SUN Huimin;XIONG Yerong;TU Jiasheng(Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs,School of Pharmacy,China Pharmaceutical University,Nanjing 210009,China;NMPA Key Laboratory for Quality Research and Evaluation of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国药科大学药学院,药用辅料及仿创药物研发评价中心,江苏南京210009 [2]中国食品药品检定研究院,国家药品监督管理局药用辅料质量研究与评价重点实验室,北京100050

出　　处：《药学研究》2020年第6期331-335,340,共6页Journal of Pharmaceutical Research

基　　金：国家科技重大专项-重大新药创制(No.2017ZX09101001-006-002);国家药典委员会-药品医疗器械审评审批制度改革专项课题(No.ZG2017-5-03)。

摘　　要：目的利用气相色谱法建立泊洛沙姆188中环氧乙烷、环氧丙烷及1,4-二氧六环的含量检查方法.方法以超纯水作为溶剂,采用顶空气相色谱法检测泊洛沙姆188中环氧乙烷、环氧丙烷及1,4-二氧六环含量.结果该方法的系统适用性、专属性、线性、精密度和准确度均符合规定,9批泊洛沙姆样品中均未检出环氧乙烷,环氧丙烷及1,4-二氧六环.结论该方法简便、准确、可靠,可用于泊洛沙姆188中环氧乙烷、环氧丙烷及1,4-二氧六环含量检测.Objective To establish a method for the determination of ethylene oxide,propylene oxide and 1,4-dioxane in Poloxamer188 by gas chromatography.Methods Using ultrapure water as solvent,the content of ethylene oxide,propylene oxide and 1,4-dioxane in Poloxamer188 was determined by headspace gas chromatography.Results The gas chromatography validation results for system suitability,specificity,linearity,precision,recovery,all met the requirement.Ethylene oxide,propylene oxide and 1,4-dioxane were not detected in the 9 batches of poloxamer samples.Conclusion The method was simple,accurate and reliable,and can be used for the detection of ethylene oxide,propylene oxide and 1,4-dioxane in Poloxamer188.

关 键 词：泊洛沙姆188 顶空气相色谱法 环氧乙烷 环氧丙烷 1 4-二氧六环 

分 类 号：R927.11[医药卫生—药学]