期刊
BIOANALYSIS
卷 12, 期 12, 页码 845-855出版社
FUTURE SCI LTD
DOI: 10.4155/bio-2020-0051
关键词
LC-MS; MS; pharmacokinetics; polymyxins; therapeutic drug monitoring
资金
- Shanghai Municipal Science and Technology Commission [17DZ1910402, 19411964900]
- Major Research and Development Project of Innovative Drugs, Ministry of Science and Technology of China [2017ZX09304005]
- National Natural Science Foundation of China [81903667]
Background: A robust and rapid method for therapeutic drug monitoring (TDM) is urgently needed for polymyxin B, which is a last-line antibiotic for multidrug-resistant gram-negative bacteria infection. Methodology: A 3-min run of LC-MS/MS method was established to determine the main components of polymyxin B (polymyxin B1 and B2) in human plasma or urine. Solid-phase extraction was employed to eliminate the matrix effect from complicated samples from patients. Results: The calibration range was 0.050-5.00 and 0.0110-0.549 mu g/ml for polymyxin B1 and B2, respectively, in plasma and urine. The precision and accuracy of quality controls, matrix effect, extraction recovery and stability were all validated and satisfied with the ICH requirements. The method was successfully applied to a pharmacokinetic study in healthy subjects and TDM in patients. Conclusion: The rapid LC-MS/MS method was validated for polymyxin B in plasma and urine, and robust for TDM.
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