Impurity profiling of micronomicin sulfate injection by liquid chromatography–ion trap mass spectrometry

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 MSn 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.

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► A better LC/MS method applied to impurity profile of micronomicin was established.
► Impurity profile of micronomicin sulfate was reported first time.
► Thirty-six impurities detected from a micronomicin sulfate injection sample were identified.
► Twenty impurities were newly identified.