Document Detail

Quantification of Rifapentine, a Potent Anti-Tuberculosis Drug, from Dried Blood Spot Samples Using Liquid Chromatographic-Tandem Mass Spectrometric Analysis.
MedLine Citation:
PMID:  25182637     Owner:  NLM     Status:  Publisher    
Quantifying anti-tuberculosis drug concentrations in multinational trials currently requires collection of modest blood volumes, centrifugation, aliquoting of plasma, freezing, and keeping samples frozen during shipping. We prospectively enrolled healthy individuals into Tuberculosis Trials Consortium Study 29B, a Phase I dose escalation study of rifapentine, a rifamycin under evaluation in tuberculosis treatment trials. We developed a liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for quantification of rifapentine in whole blood from dried blood spots (DBS) to facilitate pharmacokinetic/pharmacodynamic analyses in trials. Paired plasma and whole blood samples were collected by venipuncture; whole blood was spotted on Whatman 903® cards. Methods were optimized for plasma and then validated for DBS. The analytical measuring range was 50 to 80,000 ng/ml in whole blood DBS. Analytes were stable on cards for 11 weeks with desiccant at room temperature protected from light. Method concordance for paired plasma and whole blood DBS samples was determined after correcting for participant hematocrit or population-based estimates of bias from Bland-Altman plots. The application of either correction factor resulted in excellent correlation between plasma and whole blood DBS (Passing-Bablok regression corrected for hematocrit; y=0.98x+356). Concentrations of rifapentine may be determined from whole blood DBS collected via venipuncture after normalization to account for dilutional effects of red blood cells; additional studies are focused on the application of this methodology to capillary blood collected by finger stick. Simplicity of processing, storage, shipping and low blood volume makes whole blood DBS attractive for rifapentine pharmacokinetic evaluations, especially in international and pediatric trials.
Teresa L Parsons; Mark A Marzinke; Thuy Hoang; Erin Bliven-Sizemore; Marc Weiner; William Mac Kenzie; Susan E Dorman; Kelly E Dooley
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-9-2
Journal Detail:
Title:  Antimicrobial agents and chemotherapy     Volume:  -     ISSN:  1098-6596     ISO Abbreviation:  Antimicrob. Agents Chemother.     Publication Date:  2014 Sep 
Date Detail:
Created Date:  2014-9-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0315061     Medline TA:  Antimicrob Agents Chemother     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2014, American Society for Microbiology. All Rights Reserved.
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