Journal
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Volume 879, Issue 25, Pages 2632-2641Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.jchromb.2011.07.027
Keywords
Dalbavancin HPLC-MS/MS in plasma; Non-specific binding; Pediatric pharmacokinetic sampling; Urine sample collection; Validation; ISR
Funding
- Pfizer Inc.
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Dalbavancin is a novel second-generation lipoglycopeptide antibiotic with activity against broad range of Gram-positive pathogens. In order to determine the pharmacokinetics (PK) of dalbavancin in pediatric patients, a new High Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS) bioanalytical method has been developed for quantification of dalbavancin in plasma and in urine. The plasma method was validated for dalbavancin in the linear range from 0.5 mu g/mL to 500 mu g/mL using 50 mu L of K(2) EDTA plasma. For dalbavancin spiked in urine, non-specific binding (NSB) of the drug to polypropylene (PP) urine collection containers was observed. The loss amounted to about 10% per transfer. After successfully establishing the collection/sampling procedure for urine by addition of Triton X-100 to the collection vessels (with a purpose of preventing NSB), the method was validated for dalbavancin in the range from 0.05 mu g/mL to 50 mu g/mL, using 100 mu L of urine. These methods were used to quantify dalbavancin in plasma and urine of hospitalized children in a pediatric dalbavancin PK study. Eighteen percent of the total number of plasma study samples was reassayed for incurred samples reproducibility (ISR) and all the reassayed dalbavancin concentrations were within the +/- 20% limits. For urine, all the collected samples were reassayed for ISR and the original dalbavancin concentration was confirmed within the +/- 20% limits for 17 (94%) samples; the one remaining urine sample had its reassayed concentration confirmed within +/- 25% of the original result. (C) 2011 Elsevier B.V. All rights reserved.
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