Volume 66 Issue 11
Jan.  2023
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WU Xue, BO Meng, SUN Xiaojing, FAN Yanlong, WANG Yajing, DONG Haifeng. Determination of Genotoxic Impurities in Safinamide Mesylate by LC/MS[J]. Metrology Science and Technology, 2022, 66(11): 27-30. doi: 10.12338/j.issn.2096-9015.2021.0632
Citation: WU Xue, BO Meng, SUN Xiaojing, FAN Yanlong, WANG Yajing, DONG Haifeng. Determination of Genotoxic Impurities in Safinamide Mesylate by LC/MS[J]. Metrology Science and Technology, 2022, 66(11): 27-30. doi: 10.12338/j.issn.2096-9015.2021.0632

Determination of Genotoxic Impurities in Safinamide Mesylate by LC/MS

doi: 10.12338/j.issn.2096-9015.2021.0632
  • Accepted Date: 2022-03-31
  • Available Online: 2022-12-01
  • Publish Date: 2023-01-17
  • Safinamide mesylate is mainly used in the treatment of Parkinson's disease. A liquid chromatography-mass spectrometry (LC-MS) method was developed for the determination of genotoxic impurities ((S)-4-((1-amino-1-oxopropane-2-methyl)amino)methyl)benzoate) in safinamide mesylate. The sample was dissolved in methanol, separated by YMC-Triart C18 column (4.6mm×100 mm, 3μm), eluted with 0.1 % formic acid in water and 0.1 % formic acid in methanol gradient, and quantified by positive ion scanning in multiple reaction monitoring (MRM) mode. The method has good specificity, and the target compound has a good linear relationship in the concentration range of 1.53-30.54 ng/mL. Standard recovery rate was 98.5%~99.90% with relative standard deviations of 0.83%~2.10%. The linear response range was between 1.53~30.54 ng/mL (R2 >0.99). The results showed that the method was sensitive, accurate, reliable and suitable for screening of genotoxic impurities ((S) - 4 - ((1-amino-1-oxopropane- 2-methyl) amino) methyl) in safinamide mesylate.
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