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Published on: August 30, 2018
A sensitive human bone assay for quantitation of tigecycline using LC/MS/MS
Allena J Ji1, James P Saunders, Peter Amorusi
1Bioanalytical R & D, Wyeth Research, 401 North Middletown Road, Pearl River, NY 10965, USA. Jia@wyeth.com
Journal of Pharmaceutical and Biomedical Analysis
|August 12, 2008
Summary
A new liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay significantly improves tigecycline bone concentration measurements. This validated method reveals substantially higher tigecycline levels in human bone tissue than previously reported.
Area of Science:
- Pharmacokinetics
- Analytical Chemistry
- Biomedical Science
Background:
- Tigecycline is a broad-spectrum antibiotic effective against resistant bacteria.
- Previous analytical methods underestimated tigecycline concentrations in human bone.
- Accurate bone tissue drug levels are crucial for understanding efficacy.
Purpose of the Study:
- To develop and validate a sensitive LC/MS/MS assay for quantifying tigecycline in human bone.
- To re-evaluate tigecycline bone concentrations using an improved analytical method.
Main Methods:
- A novel assay involving sample stabilization, acidic-methanol extraction, and LC/MS/MS detection was developed.
- Assay validation included linearity, accuracy, precision, and stability assessments.
- The method was applied to human bone samples from subjects receiving tigecycline.
Main Results:
- The validated assay demonstrated linearity from 50 to 20,000 ng/g.
- Accuracy was within ±15% and precision (CV) was <15%.
- Re-analysis of human bone samples showed mean tigecycline concentrations 9 times higher than previously reported.
Conclusions:
- The developed LC/MS/MS method provides significantly higher extraction efficiency for tigecycline from human bone.
- This improved assay offers more accurate quantification of tigecycline bone penetration.
- Findings necessitate a re-evaluation of tigecycline's pharmacokinetic profile in bone tissue.
