Sulfur-Specific Detection of Impurities in Cimetidine Drug Substance Using Liquid Chromatography Coupled to High Resolution Inductively Coupled Plasma Mass Spectrometry and Electrospray Mass Spectrome
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文摘
The use of liquid chromatography coupled to sector fieldinductively coupled plasma mass spectrometry (SF-ICP-MS) for the specific detection of sulfur-containing compounds is described. In the sulfur-containing drug substance cimetidine, structurally related impurities wellbelow the 0.1% mass fraction level relative to the maindrug substance could easily be detected. The structureof most of the impurities was confirmed by electrospraymass spectrometry (ESI-MS), and thus, the complementarity of the two techniques for drug analysis is shown.The limit of detection by SF-ICP-MS for cimetidine insolution was ~4-20 ng·g-1, but it was blank-limited.

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