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PENG Shiyan, CHEN Hua, YIN Jie. Determination of azide genotoxic impurity in linezolid API and glucose injection by UPLC-MS/MS[J]. Journal of China Pharmaceutical University, 2022, 53(6): 705-709. DOI: 10.11665/j.issn.1000-5048.20220609
Citation: PENG Shiyan, CHEN Hua, YIN Jie. Determination of azide genotoxic impurity in linezolid API and glucose injection by UPLC-MS/MS[J]. Journal of China Pharmaceutical University, 2022, 53(6): 705-709. DOI: 10.11665/j.issn.1000-5048.20220609
shu

Determination of azide genotoxic impurity in linezolid API and glucose injection by UPLC-MS/MS

  • 1.

    School of Pharmacy, China Pharmaceutical University, Nanjing 211198

  • 2.

    National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Chemical Drugs, National Institutes for Food and Drug Control, Beijing 102629, China

Funds: This study was supported by the Discipline Construction Funding Project of National Medical Products Administration Key Laboratory for Quality Research and Evaluation of Chemical Drugs (No. 1030050090124)
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  • Received Date: July 03, 2022
  • Revised Date: November 24, 2022
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    • Abstract
  • A UPLC-MS/MS method was established for the determination of the genotoxic impurity (R)-5-(azidomethyl)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxazolidinone in linezolid API and its glucose injection. Chromatographic separation was performed on a Waters Acquity UPLC HSS T3 column (100 mm × 2.1 mm, 1.8 μm) with 0.1% formic acid water-0.1% formic acid acetonitrile (60∶40) at a flow rate of 0.3 mL/min. The UPLC-MS/MS was equipped with electrospray ionization in positive ionization mode and multiple reaction monitoring mode. The results showed that the calibration curve was linear in the range of 4-12 ng/mL and the limit of quantification was 0.073 ng/mL.The average recoveries of the low, medium and high concentration (80%,100%,120% limit concentration) loading solutions were 101.14%, 100.59% and 101.47%, respectively (RSDs:0.73%, 1.10% and 0.91%, respectively).The sample solution was stable for 6 d.No genotoxic impurity of (R)-5-(Azidomethyl)-3-[3-fluoro-4-(4-morpholinyl)phenyl]-2-oxazolidinonewas not detected in the samples of linezolid API and its glucose injection.
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    • References (4)
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    [2]
    Brickner SJ，Hutchinson DK，Barbachyn MR，et al. Synthesis and antibacterial activity of U-100592 and U-100766，two oxazolidinone antibacterial agents for the potential treatment of multidrug-resistant gram-positive bacterial infections［J］. J Med Chem，1996，39（3）：673-679.
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