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注射用二羟丙茶碱有关物质的HPLC-QTOF MS分析
引用本文:任美婷,宋冬梅,江文明,杨永健. 注射用二羟丙茶碱有关物质的HPLC-QTOF MS分析[J]. 中国医药工业杂志, 2012, 43(6): 463-465
作者姓名:任美婷  宋冬梅  江文明  杨永健
作者单位:上海市食品药品检验所,上海,201203
基金项目:上海市食品药品监督管理局课题(kt-20101101391)资助
摘    要:建立了高效液相色谱-四极/飞行时间质谱法测定注射用二羟丙茶碱中的有关物质.采用Eclipse plus C18色谱柱,以0.1%甲酸-甲醇(72∶28)为流动相.采用正离子模式采集数据.注射液中共检出4个有关物质,推断分别为茶碱、茶碱与二羟丙茶碱的聚合体、二羟丙茶碱的二聚体及其同分异构体.

关 键 词:二羟丙茶碱  有关物质  高效液相色谱-四极/飞行时间质谱

Determination of Related Substances in Diprophylline for Injection by HPLC-QTOF MS
REN Meiting , SONG Dongmei , JIANG Wenming , YANG Yongjian. Determination of Related Substances in Diprophylline for Injection by HPLC-QTOF MS[J]. , 2012, 43(6): 463-465
Authors:REN Meiting    SONG Dongmei    JIANG Wenming    YANG Yongjian
Affiliation:(Shanghai Institute for Food and Drug Control,Shanghai 201203)
Abstract:An HPLC-QTOF MS method was established for the determination of the related substances in diprophylline for injection.A Eclipse plus C18 column was used with the mobile phase of 0.1% formic acid-methanol(72︰28).The data was acquired in positive ion mode.Four related substances were detected in diprophylline for injection and inferred as theophylline,the polymer of theophylline and diprophylline,diprophylline-dimer and its isomer,respectively.
Keywords:diprophylline  related substance  HPLC-QTOF MS
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