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已发表论文
用于人血浆中三种噁唑烷酮类抗菌药物同时定量的液相色谱 - 串联质谱法：在治疗药物监测中的应用
Authors Zhang N, Bai N, Wang Y, Liang B, Cai Y
Received 7 July 2025
Accepted for publication 19 September 2025
Published 1 October 2025 Volume 2025:19 Pages 8903—8917
DOI https://doi.org/10.2147/DDDT.S547979
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Tuo Deng
Na Zhang,* Nan Bai,* Ying Wang, Beibei Liang, Yun Cai
Center of Medicine Clinical Research, Department of Pharmacy, Medical Supplies Center, PLA General Hospital, Beijing, 100853, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Yun Cai, Center of Medicine Clinical Research, Department of Pharmacy, Medical Supplies Center, PLA General Hospital, 28 Fu Xing Road, Beijing, 100853, People’s Republic of China, Tel +86-10-6693-7166, Fax +86-10-8821-4425, Email caicai_hh@126.com
Background: Oxazolidinone antimicrobials, which are effective against multidrug-resistant gram-positive pathogens, face challenges of variable efficacy and safety owing to patient pharmacokinetic differences.
Purpose: This study aimed to establish a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to simultaneously quantify multiple oxazolidinone antimicrobials, including linezolid, tedizolid, and contezolid, for therapeutic drug monitoring (TDM) applications.
Methods: Chromatographic separation was achieved on a C18 column (100 × 2.1 mm, 3.5 μm) with gradient elution. Detection was performed via positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode, targeting transitions: m/z 338.14→ 162.8 (linezolid); m/z 371→ 343.1 (tedizolid) and m/z 409.15→ 269.14 (contezolid), with voriconazole-d3 as the internal standard.
Results: The method was validated using Bioanalytical Method Validation (M10). The method demonstrated high selectivity and wide linear ranges of 50.0– 15,000.0 ng/mL for linezolid and contezolid, and 25.0– 7500.0 ng/mL for tedizolid, respectively, with a good linearity (R2 > 0.993). The intra- and inter-day accuracy and precision were within acceptable limits. Recovery ranged from 94.4% to 104.2% in plasma, and matrix effects were negligible (CV%< 3.6%). Stability experiments confirmed analyte integrity under short-term (8 h at room temperature), long-term (34 days at − 80°C for linezolid; 40 days for tedizolid and contezolid), and freeze-thaw conditions. No carry-over contamination was exhibited. This method has been successfully applied to monitor the concentrations of both drugs during the transition between linezolid and contezolid therapy.
Conclusion: This validated LC-MS/MS method enables the simultaneous determination of linezolid, tedizolid, and contezolid in human plasma, rendering it promising for pharmacokinetic studies and TDM, and contributing to optimized patient care in complex therapeutic scenarios.
Keywords: oxazolidinone, linezolid, tedizolid, contezolid, LC-MS/MS
Center of Medicine Clinical Research, Department of Pharmacy, Medical Supplies Center, PLA General Hospital, Beijing, 100853, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Yun Cai, Center of Medicine Clinical Research, Department of Pharmacy, Medical Supplies Center, PLA General Hospital, 28 Fu Xing Road, Beijing, 100853, People’s Republic of China, Tel +86-10-6693-7166, Fax +86-10-8821-4425, Email caicai_hh@126.com
Background: Oxazolidinone antimicrobials, which are effective against multidrug-resistant gram-positive pathogens, face challenges of variable efficacy and safety owing to patient pharmacokinetic differences.
Purpose: This study aimed to establish a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to simultaneously quantify multiple oxazolidinone antimicrobials, including linezolid, tedizolid, and contezolid, for therapeutic drug monitoring (TDM) applications.
Methods: Chromatographic separation was achieved on a C18 column (100 × 2.1 mm, 3.5 μm) with gradient elution. Detection was performed via positive electrospray ionization (ESI+) in multiple reaction monitoring (MRM) mode, targeting transitions: m/z 338.14→ 162.8 (linezolid); m/z 371→ 343.1 (tedizolid) and m/z 409.15→ 269.14 (contezolid), with voriconazole-d3 as the internal standard.
Results: The method was validated using Bioanalytical Method Validation (M10). The method demonstrated high selectivity and wide linear ranges of 50.0– 15,000.0 ng/mL for linezolid and contezolid, and 25.0– 7500.0 ng/mL for tedizolid, respectively, with a good linearity (R2 > 0.993). The intra- and inter-day accuracy and precision were within acceptable limits. Recovery ranged from 94.4% to 104.2% in plasma, and matrix effects were negligible (CV%< 3.6%). Stability experiments confirmed analyte integrity under short-term (8 h at room temperature), long-term (34 days at − 80°C for linezolid; 40 days for tedizolid and contezolid), and freeze-thaw conditions. No carry-over contamination was exhibited. This method has been successfully applied to monitor the concentrations of both drugs during the transition between linezolid and contezolid therapy.
Conclusion: This validated LC-MS/MS method enables the simultaneous determination of linezolid, tedizolid, and contezolid in human plasma, rendering it promising for pharmacokinetic studies and TDM, and contributing to optimized patient care in complex therapeutic scenarios.
Keywords: oxazolidinone, linezolid, tedizolid, contezolid, LC-MS/MS