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WU Xue, BO Meng, SUN Xiaojing, FAN Yanlong, WANG Yajing, DONG Haifeng. Determination of Genotoxic Impurities in Safinamide Mesilate by LC/MS[J]. Metrology Science and Technology. 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 Mesilate by LC/MS[J]. Metrology Science and Technology. doi: 10.12338/j.issn.2096-9015.2021.0632

Determination of Genotoxic Impurities in Safinamide Mesilate by LC/MS

doi: 10.12338/j.issn.2096-9015.2021.0632
  • Accepted Date: 2022-03-31
  • Available Online: 2022-04-22
  • Salofamide mesylate is mainly used to treat Parkinson's disease. A LC/MS method was developed for the determination of genotoxic impurities ((S) - 4 - ((1-amino-1-oxopropane-2-methyl) amino) methyl) in safinamide mesilate. The sample was dissolved in methanol, separated on YMC-Triart C18 column (4.6mm×100 mm, 3μm), mobile phase: water (containing 0.1% formic acid) -methanol (containing 0.1% formic acid), gradient elution, and finally detected with a mass spectrometer detector. Under the condition of selected chromatography, genotoxic impurities can separate well. The LODs was 0.76 mg/kg and the LOQs was 1.53 mg/kg. 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 mesilate.
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