Beijing Sun-Novo Pharmaceutical Research Company Ltd, Yunguyuan, No.79 Shuangying West Road, Changping District, Beijing, 102200, People's Republic of China.
Department of Pharmaceutical and Pharmacological Sciences, Pharmaceutical Analysis, KU Leuven, O&N2, PB 923, Herestraat 49, 3000, Leuven, Belgium.
Sci Rep. 2022 Jul 8;12(1):11665. doi: 10.1038/s41598-022-15625-5.
Metronidazole in aqueous solution is sensitive to light and UV irradiation, leading to the formation of N-(2-hydroxyethyl)-5-methyl-l,2,4-oxadiazole-3-carboxamide. This is revealed here by liquid chromatography with tandem photo diode array detection and mass spectrometry (LC-PDA-MS) and further verified by comparison with the corresponding reference substance and proton nuclear magnetic resonance (H-NMR). However, in current compendial tests for related substances/organic impurities of metronidazole, the above photolytic degradant could not be detected. Thus, when photodegradation of metronidazole occurs, it could not be demonstrated. In our study, an improved LC method was developed and validated, which includes a detection at a wavelength of 230 nm and optimization of mobile phase composition thereby a better separation was obtained.
甲硝唑水溶液对光和紫外光敏感，会生成 N-(2-羟乙基)-5-甲基-1,2,4-噁二唑-3-甲酰胺。本文通过液相色谱-串联光电二极管阵列检测-质谱联用（LC-PDA-MS）进行了研究，并与相应的对照品和质子核磁共振（H-NMR）进行了比较，从而得到了证实。然而，在当前的甲硝唑相关物质/有机杂质的药典测试中，无法检测到上述光解产物。因此，当甲硝唑发生光降解时，无法进行证明。在我们的研究中，开发并验证了一种改进的 LC 方法，包括在 230nm 波长下进行检测，并优化流动相组成，从而获得了更好的分离效果。
