Abstract

Background: Cefoselis sulfate similarly to other 4th generation cephalosporin is vulnerable for degradation in aqueous solution.

Methods: For identification cefoselis sulfate degradation products chromatographic system consisting of Kinetex, C18, 100A, 100 × 2.1 mm, particle size 5 µm column, mobile phase: acetonitrile – 0.1% formic acid (5:95 V/V) and a hybrid ESI-Q-TOF mass spectrometer was used.

Results: Masses of degradation products with high accuracy (0.09 - 4.64 ppm) were found. Following formulas were obtained: 128.08243 (C₅H₁₀N₃O), 243.05471 (C₈H₁₀N₄O₃S), 370.06338 (C₁₃H₁₆N₅O₄S₂), 414.05324 (C₁₄H₁₆N₅O₆S₂), 451.13191 (C₁₇H₂₃N₈O₃S₂), 479.12777 (C₁₈H₂₂N₈O₄S₂) and 523.11859 (C₁₉H₂₃N₈O₆S₂) - cefoselis sulfate.

Conclusions: Five previously unknown and one known impurities of CSS were identified by HPLCMS/ MS Degradation pathways of cefoselis sulfate in aqueous solutions were suggested.

Keywords: Cefoselis Sulfate, HPLC, Q-TOF, Degradation in Aqueous Solutions, Identification of Degradation Products.

Graphical Abstract