Objective:To establish an HPLC-MS/MS analytical method for the determination of genotoxic impurities in tedizolid phosphate.Methods:Chromatographic separation was performed on an Waters Acquity BEH C18(2.1 mm×100 mm,1.7 μm)column using the mobile phase consisting of 20 mmol ammonium acetate(mobile phase A)and acetonitrile(mobile phase B)by gradient elution.The electrospray was operated in an ESI under posive ionization scanning mode with SIM.Selective ion monitors were set at m/z 389.1 for TDZA010,m/z 310.0 for TDZA046.Results:The correlation curves of genotoxic impurities TDZA010,TDZA046 were in good linearity in the range of 30%～150%limit concentration.The detection limits were 1 ng·mL-1 and the quantitation limits were 3 ng·mL-1.The recoveries were between 89.8%to 105.3%and RSD(n=12)were 5.3%,4.6%.The repeatabilities RSD were 0.4%,3.3%.Conclusion:This method is simple,slective,sensitive,and quite suitable for the determination of genotoxic impurities TDZA010,TDZA046 in tedizolid phosphate.
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