Determination of Genotoxic Impurities in Safinamide Mesilate by LC/MS

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

doi:10.12338/j.issn.2096-9015.2021.0632

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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

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Determination of Genotoxic Impurities in Safinamide Mesilate 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, Shijiazhuang 050000, China

Accepted Date: 2022-03-31

Available Online: 2022-04-22

Abstract

Abstract

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.
- safinamide mesilate,
- liquid chromatography/ mass spectrometry,
- genotoxic impurities,
- detection

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References(19)

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