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<p>This study aims to develop a structural analysis method for biapenem and the impurities based on high performance liquid chromatography-quadrupole/time of flight-tandem mass spectrometry (HPLC-Q/TOF-MS/MS). The biapenem sample and the acid treated degradation solution were separated on a Dikma Diamonsil C18 analytical column (250&#xa0;mm × 4.6&#xa0;mm i.d., 5&#xa0;μm). The 10 mM ammonium acetate aqueous solution was used as mobile phase A, and acetonitrile was used as mobile phase B under gradient elution. The MS was operated on positive electrospray ionization mode, and the collision energy was optimized to be 15&#xa0;eV. The fragmentation pathways were systematically summarized for biapenem and the impurities. Neutral loss of CO<sub>2</sub>, CO, H<sub>2</sub>O, propylene, propyne, acetaldehyde, ethanol were used for the characterization of the ions structures. New kinds of 5&#xa0;H-pyrazolo[1,2-a][1,2,4]triazol-4-ium (PTI), enone-type ion, allylium were reported. Besides the known ring-opening Impurity I and Impurity II, dimer A and dimer B, the structures of six impurities (Impurity III to Impurity VIII) such as ketone impurity, formylation product, hydroxyl impurity were proposed. The fragmentation pathway provides a reliable tool for structural analysis of the impurities of biapenem, facilitating quality control of marketed drugs.</p>

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Fragmentation pathways of biapenem and its impurities using high performance liquid chromatography quadrupole time of flight tandem mass spectrometry

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月17日

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  • Hanzhi Zhang,
  • Xiakun Wang,
  • Bingyue Fu

摘要

This study aims to develop a structural analysis method for biapenem and the impurities based on high performance liquid chromatography-quadrupole/time of flight-tandem mass spectrometry (HPLC-Q/TOF-MS/MS). The biapenem sample and the acid treated degradation solution were separated on a Dikma Diamonsil C18 analytical column (250 mm × 4.6 mm i.d., 5 μm). The 10 mM ammonium acetate aqueous solution was used as mobile phase A, and acetonitrile was used as mobile phase B under gradient elution. The MS was operated on positive electrospray ionization mode, and the collision energy was optimized to be 15 eV. The fragmentation pathways were systematically summarized for biapenem and the impurities. Neutral loss of CO2, CO, H2O, propylene, propyne, acetaldehyde, ethanol were used for the characterization of the ions structures. New kinds of 5 H-pyrazolo[1,2-a][1,2,4]triazol-4-ium (PTI), enone-type ion, allylium were reported. Besides the known ring-opening Impurity I and Impurity II, dimer A and dimer B, the structures of six impurities (Impurity III to Impurity VIII) such as ketone impurity, formylation product, hydroxyl impurity were proposed. The fragmentation pathway provides a reliable tool for structural analysis of the impurities of biapenem, facilitating quality control of marketed drugs.