Title: Impurity profiling of micronomicin sulfate injection by liquid chromatography-ion trap mass spectrometry
Authors: Yuan, Yao-Zuo
Zhao, Xun
Zhang, Mei
Fan, Xia-Lei
Hu, Chang-Qin
Jin, Shao-Hong
Van Schepdael, Ann
Hoogmartens, Jos
Adams, Erwin # ×
Issue Date: Mar-2013
Publisher: Pergamon Press
Series Title: Journal of Pharmaceutical and Biomedical Analysis vol:75 pages:94-104
Abstract: The characterization of impurities present in micronomicin sulfate injection by liquid chromatography (LC) coupled with mass spectrometry (MS) is described. A reversed phase (RP)-LC method using a C(18) column resistant to an alkaline (pH 11) aqueous mobile phase was developed and coupled to MS with an electrospray ionization (ESI) source in the positive ion mode which provides MS(n) capability. A total of thirty six impurities were detected in commercial samples: five impurities were identified by comparison of their fragmentation patterns with those of available related substances, eleven of them were identified in accordance with relevant literature, while the other twenty impurities were newly identified using the MS/MS spectra of the available related reference substances as interpretative templates combined with knowledge of the nature of functional group fragmentation behaviors. This work was applied to evaluate the quality of micronomicin sulfate injection from different manufacturers.
ISSN: 0731-7085
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Pharmaceutical Analysis
× corresponding author
# (joint) last author

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