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首页> 外文期刊>Rapid Communications in Mass Spectrometry: RCM >Identification of the 'wrong' active pharmaceutical ingredient in a counterfeit Halfan (TM) drug product using accurate mass electrospray ionisation mass spectrometry, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry
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Identification of the 'wrong' active pharmaceutical ingredient in a counterfeit Halfan (TM) drug product using accurate mass electrospray ionisation mass spectrometry, accurate mass tandem mass spectrometry and liquid chromatography/mass spectrometry

机译：使用准确的电喷雾质谱，准确的串联质谱和液相色谱/质谱法鉴定假冒的Halfan（TM）药品中的“错误”活性药物成分

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摘要

Methodology is presented for identifying an unknown active (pharmaceutical) ingredient (AT) in a counterfeit drug product. A range of mass spectrometric techniques, i.e., accurate mass mass spectrometry, tandem mass spectrometry (MS/MS) and liquid chromatography/mass spectrometry (LC/MS), has been employed to determine the AT in a counterfeit Halfan(TM) suspension, an antimalarial drug. In particular, use of LockSpray accurate mass MS/MS allowed identification of parts of the molecule from fragments, hence limiting the number of possible elemental compositions for the nominal mass of 278 found for the AT in the counterfeit product. The analysis of the isotope pattern observed for the protonated molecule further reduced the number of possible elemental compositions. A literature search for readily commercially available compounds of molecular formula C12H14N4O2S suggested that the AT was either sulfamethazine or sulfisomidine. An LC/MS separation of those two compounds and reference MS/MS spectra obtained for sulfamethazine and sulfisomidine led to the conclusion that the AT in the counterfeit Halfan(TM) suspension is sulfamethazine, which is an antibacterial agent. Copyright (C) 2002 John Wiley Sons, Ltd. [References: 17]
机译：提出了用于识别假药产品中未知的活性（药物）成分（AT）的方法。一系列质谱技术，即精确质谱，串联质谱（MS / MS）和液相色谱/质谱（LC / MS）已用于确定仿冒Halfan（TM）悬浮液中的AT，抗疟药。特别是，使用LockSpray精确质量MS / MS可以从片段中鉴定出分子的一部分，从而限制了假冒产品中AT的标称质量为278的可能元素组成的数量。对质子化分子观察到的同位素模式的分析进一步减少了可能的元素组成的数量。文献中对分子式为C12H14N4O2S的可商购化合物的研究表明，AT可能是磺胺二甲嘧啶或磺胺异m啶。 LC / MS分离这两种化合物以及获得的磺胺二甲基嘧啶和磺胺异iso啶的参考MS / MS光谱得出的结论是，仿冒的HalfanTM悬浮液中的AT是磺胺二甲基嘧啶，它是一种抗菌剂。版权所有（C）2002 John Wiley Sons，Ltd. [引用：17]

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