首批还原型谷胱甘肽杂质国家对照品的研制.pdfVIP

24 2010 24 3 王 悦, 郝苏丽, 杨化新, 范慧红( , 100050) : 建立首批还原型谷胱甘肽中氧化型谷胱甘肽杂质对照品 以茚三酮试验进行鉴别, 应 用 质联用仪红外光谱仪对氧化型谷胱甘肽进行结构确证, 反相高效 相色谱法使用2 种流动相体系进 行纯度测定比较, 用质量平衡法计算含量确证了氧化型谷胱甘肽原料的结构, 并确定首批氧化型 谷胱甘肽对照品含量为936% 首批氧化型谷胱甘肽国家对照品 (批号: 140746200 01) 的建立方 便了还原型谷胱甘肽中氧化型谷胱甘肽杂质的定性和定量控制 : 谷胱甘肽; 氧化型谷胱甘肽; 对照品; HPLC : R915 : A : ( 2010) 03024 03 Standardizationof theNationalReference Standardof theImpurity of Glutathione Wang Yue, Hao Suli, Yang Huaxin and Fan Huihong( National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050) ABSTRACT: Objective To establish the national reference standard for oxidized glutathione ( GSSG) . ethodsLCM S and IR Spectrometer w ere used to confirm the structure of the material. Tw o mobile phases w ere used to determine the purity of oxidized glutathione by HPLC, and the content of the product w as calculated by mass balance method. ResultsT he structure of the material has been confirmed, and the content of oxidized glutathione w as 936% . ConclusionT he establishment of national reference standard of oxidized glutathione can efficiently control the quality and quantity of oxidized glutathione in glutathione. KEYWORDS: glutathione; oxidized glutathione; national reference standard; HPLC , , , , 1 Waters ( 1525 , 24 7 , [ 1] , , 717plus , EMPOWER ) ; , Mettler T oledo ; WRB1B ; FEB 115 ; M ettler Toledo MP230 7 ; Thermo Nicolet NEXU S FTIR ; Finigan LCQ DECA XP Plus ; Perkin , 2 Elmer Model 343 Plus , :