Journal
BIOANALYSIS
Volume 7, Issue 12, Pages 1423-1434Publisher
FUTURE SCI LTD
DOI: 10.4155/bio.15.76
Keywords
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Funding
- AstraZeneca
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Aim: Avibactam, a novel non--lactam -lactamase inhibitor co-administrated with the -lactam antibiotic ceftazidime, is in clinical development. The need to evaluate its PK and PD requires accurate and reliable bioanalytical methods. Methods: We describe LC-MS/MS methods for the determination of avibactam and ceftazidime in human plasma. Avibactam was extracted using weak anionic exchange solid-phase extraction and analyzed on an amide column. Ceftazidime was extracted using protein precipitation and analyzed on a C18 column. Calibration curves were established over 10-10,000 ng/ml (avibactam) and 43.8-87,000 ng/ml (ceftazidime). Results & conclusion: Method validation, cross-validation between three laboratories and incurred sample re-analysis demonstrated method robustness. The methods were successfully applied to multiple clinical studies.
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