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Bioanalysis. 2015;7(12):1423-34. doi: 10.4155/bio.15.76.

Determination of avibactam and ceftazidime in human plasma samples by LC-MS.

Author information

1
AstraZeneca R&D, Mölndal, Sweden.
2
Covance, Harrogate, HG3 1PY, UK.
3
LGC, Fordham, Cambridgeshire, CB7 5WW, UK.
4
AstraZeneca, Macclesfield, Cheshire East SK10 2NA, UK.
5
Quotient Bioresearch, Rushden, Northamptonshire, NN10 6ER, UK.

Abstract

AIM:

Avibactam, a novel non-β-lactam β-lactamase inhibitor co-administrated with the β-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.

PMID:
26168250
DOI:
10.4155/bio.15.76
[Indexed for MEDLINE]

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