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

被引:45
作者
Sillen, Henrik [1 ]
Mitchell, Richard [2 ]
Sleigh, Rebecca [3 ]
Mainwaring, Guy [4 ]
Catton, Katherine [2 ]
Houghton, Richard [5 ]
Glendining, Karen [4 ]
机构
[1] AstraZeneca R&D, Molndal, Sweden
[2] Covance, Harrogate HG3 1PY, N Yorkshire, England
[3] LGC, Fordham CB7 5WW, Cambs, England
[4] AstraZeneca, Macclesfield SK10 2NA, Cheshire East, England
[5] Quotient Biores, Rushden NN10 6ER, Northants, England
关键词
LACTAMASE-PRODUCING ENTEROBACTERIACEAE; IN-VITRO ACTIVITY; GRAM-NEGATIVE BACTERIA; PSEUDOMONAS-AERUGINOSA; KLEBSIELLA-PNEUMONIAE; LIQUID-CHROMATOGRAPHY; NXL104; COMBINATIONS; BETA-LACTAMASES; CARBAPENEMASES; INFECTIONS;
D O I
10.4155/bio.15.76
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
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.
引用
收藏
页码:1423 / 1434
页数:12
相关论文
共 27 条
[1]   In vitro activity of avibactam (NXL104) in combination with β-lactams against Gram-negative bacteria, including OXA-48 β-lactamase-producing Klebsiella pneumoniae [J].
Aktas, Z. ;
Kayacan, C. ;
Oncul, O. .
INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS, 2012, 39 (01) :86-89
[2]  
[Anonymous], 2001, Guidance for industry - bioanalytical method validation
[3]   Bad Bugs, No Drugs: No ESKAPE! An Update from the Infectious Diseases Society of America [J].
Boucher, Helen W. ;
Talbot, George H. ;
Bradley, John S. ;
Edwards, John E., Jr. ;
Gilbert, David ;
Rice, Louis B. ;
Scheld, Michael ;
Spellberg, Brad ;
Bartlett, John .
CLINICAL INFECTIOUS DISEASES, 2009, 48 (01) :1-12
[4]   Activity of Ceftaroline-Avibactam Tested against Gram-Negative Organism Populations, including Strains Expressing One or More β-Lactamases and Methicillin-Resistant Staphylococcus aureus Carrying Various Staphylococcal Cassette Chromosome mec Types [J].
Castanheira, Mariana ;
Sader, Helio S. ;
Farrell, David J. ;
Mendes, Rodrigo E. ;
Jones, Ronald N. .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2012, 56 (09) :4779-4785
[5]   Activities of Ceftazidime and Avibactam against β-Lactamase-Producing Enterobacteriaceae in a Hollow-Fiber Pharmacodynamic Model [J].
Coleman, Ken ;
Levasseur, Premavathy ;
Girard, Anne-Marie ;
Borgonovi, Monica ;
Miossec, Christine ;
Merdjan, Henri ;
Drusano, George ;
Shlaes, David ;
Nichols, Wright W. .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2014, 58 (06) :3366-3372
[6]   Randomized, Placebo-Controlled Study to Assess the Impact on QT/QTc Interval of Supratherapeutic Doses of Ceftazidime-Avibactam or Ceftaroline Fosamil-Avibactam [J].
Das, Shampa ;
Armstrong, Jon ;
Mathews, David ;
Li, Jianguo ;
Edeki, Timi .
JOURNAL OF CLINICAL PHARMACOLOGY, 2014, 54 (03) :331-340
[7]  
Deshpando DA, 2004, CURRENT SCI, V87, P1684
[8]   Determination of ceftazidime in plasma using high-performance liquid chromatography and electrochemical detection - Application for individualizing dosage regimens in elderly patients [J].
Guitton, J ;
Laffont, A ;
Bruzeau, J ;
Rochet-Mingret, L ;
Bonnefoy, M ;
Bureau, J .
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES, 1998, 719 (1-2) :151-157
[9]   Current Concepts in Antimicrobial Therapy Against Resistant Gram-Negative Organisms: Extended-Spectrum β-Lactamase Producing Enterobacteriaceae, Carbapenem-Resistant Enterobacteriaceae, and Multidrug-Resistant Pseudomonas aeruginosa [J].
Kanj, Souha S. ;
Kanafani, Zeina A. .
MAYO CLINIC PROCEEDINGS, 2011, 86 (03) :250-259
[10]   Activity of NXL104 in Combination with β-Lactams against Genetically Characterized Escherichia coli and Klebsiella pneumoniae Isolates Producing Class A Extended-Spectrum β-Lactamases and Class C β-Lactamases [J].
Lagace-Wiens, P. R. S. ;
Tailor, F. ;
Simner, P. ;
DeCorby, M. ;
Karlowsky, J. A. ;
Walkty, A. ;
Hoban, D. J. ;
Zhanel, G. G. .
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 2011, 55 (05) :2434-2437