title: Impurity profiling of micronomicin sulfate injection by liquid chromatography-ion trap mass spectrometry.
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 C₁₈ 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.
authors.affiliation: Jiang Su Institute for Food and Drug Control, Nanjing 210008, China.
authors.forename: Yao-zuo
authors.initials: YZ
authors.lastname: Yuan
authors.forename: Xun
authors.initials: X
authors.lastname: Zhao
authors.forename: Mei
authors.initials: M
authors.lastname: Zhang
authors.forename: Xia-Lei
authors.initials: XL
authors.lastname: Fan
authors.forename: Chang-qin
authors.initials: CQ
authors.lastname: Hu
authors.forename: Shao-hong
authors.initials: SH
authors.lastname: Jin
authors.forename: Ann
authors.initials: A
authors.lastname: Van Schepdael
authors.forename: Jos
authors.initials: J
authors.lastname: Hoogmartens
authors.forename: Erwin
authors.initials: E
authors.lastname: Adams
mesh_terms: D000617:Aminoglycosides / Q000008:administration & dosage / Q000737:chemistry* / Q000191:economics; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry* / Q000191:economics; D002681:China; D002851:Chromatography, High Pressure Liquid; D056148:Chromatography, Reverse-Phase; D004340:Drug Contamination; D005839:Gentamicins; D007267:Injections; D015394:Molecular Structure; D011786:Quality Control; D021241:Spectrometry, Mass, Electrospray Ionization; D013463:Sulfuric Acid Esters / Q000008:administration & dosage / Q000737:chemistry / Q000191:economics; D053719:Tandem Mass Spectrometry
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D005839:Gentamicins; D013463:Sulfuric Acid Esters; C037545:micronomicin