Document Detail


Determination of fenofibric acid concentrations by HPLC after anion exchange solid-phase extraction from human serum.
MedLine Citation:
PMID:  17417074     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Triglycerides are increasingly being recognized as a risk factor for cardiovascular disease. Research efforts to identify sources of variability in triglyceride-lowering response to the lipid-lowering drug fenofibrate require quantification of the active acidic form of this PPAR-alpha agonist. Anion-exchange solid-phase extraction, in combination with reverse-phase high-performance liquid chromatography (HPLC), rapidly and accurately determines steady-state fenofibric acid serum concentrations. Chromatographic separation under isocratic conditions, with use of ultraviolet detection at 285 nm, provides clean baseline and sharp peaks for clofibric acid, 1-napthyl acetic acid (internal standards), and fenofibric acid. Commonly prescribed and over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) were screened for assay interference, and the assay was employed to quantify fenofibric acid in more than 800 human subject specimens. Fenofibric acid analysis was found to be linear over the range of 0.5 to 40 mg/L and was validated with either internal standard. Accuracies ranged from 98.65% to 102.4%, whereas the within- and between-day precisions ranged from 1.0% to 2.2% and 2.0% to 6.2%, respectively. NSAIDs had minimal interference with the assay, which succeeded in quantifying fenofibric acid in more than 843 of 846 serum samples from human subjects, many taking a variety of coadministered medications. Anion-exchange solid-phase extraction in combination with reverse-phase HPLC accurately determines steady-state fenofibric acid serum concentrations in humans without interference from NSAIDs or commonly administered medications. This method is suitable for quantification of fenofibric acid for clinical pharmacokinetic studies in patients with dyslipidemia.
Authors:
Robert J Straka; R Todd Burkhardt; James E Fisher
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Therapeutic drug monitoring     Volume:  29     ISSN:  0163-4356     ISO Abbreviation:  Ther Drug Monit     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-09     Completed Date:  2007-06-21     Revised Date:  2007-12-03    
Medline Journal Info:
Nlm Unique ID:  7909660     Medline TA:  Ther Drug Monit     Country:  United States    
Other Details:
Languages:  eng     Pagination:  197-202     Citation Subset:  IM    
Affiliation:
University of Minnesota College of Pharmacy, Department of Experimental and Clinical Pharmacology, Minneapolis, Minnesota, USA. strak001@umn.edu
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MeSH Terms
Descriptor/Qualifier:
Anion Exchange Resins
Anti-Inflammatory Agents, Non-Steroidal / blood
Antilipemic Agents / blood*
Chromatography, High Pressure Liquid / methods
Drug Stability
Humans
Procetofen / analogs & derivatives*,  blood
Sensitivity and Specificity
Solid Phase Extraction / methods
Grant Support
ID/Acronym/Agency:
7 U01 HL072524-03/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Anion Exchange Resins; 0/Anti-Inflammatory Agents, Non-Steroidal; 0/Antilipemic Agents; 26129-32-8/fenofibric acid; 49562-28-9/Procetofen

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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