Determination of Genotoxic Impurities in Safinamide Mesylate by LC/MS

WU Xue; BO Meng; SUN Xiaojing; FAN Yanlong; WANG Yajing; DONG Haifeng

doi:10.12338/j.issn.2096-9015.2021.0632

Volume 66 Issue 11

Jan. 2023

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Article Navigation > Metrology Science and Technology > 2022 > 66(11): 27-30

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

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Determination of Genotoxic Impurities in Safinamide Mesylate by LC/MS

doi: 10.12338/j.issn.2096-9015.2021.0632

1.
National Institute of Metrology, Beijing 100029, China
2.
Drug Research Institute of Shijiazhuang No.4 Pharmaceutical Co., Ltd, Institute of Chemical Pharmaceutical Sterile Preparation Industry Technology, Shijiazhuang 050000, China

Accepted Date: 2022-03-31

Available Online: 2022-12-01

Publish Date: 2023-01-17

Abstract

Abstract

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.
- safinamide mesylate,
- liquid chromatography-mass spectrometry,
- genotoxic impurities,
- quantitative detection,
- Parkinson's disease

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References(19)

References

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