Document Detail


Determination of clarithromycin in human serum by high-performance liquid chromatography after pre-column derivatization with 9-fluorenylmethyl chloroformate: application to a bioequivalence study.
MedLine Citation:
PMID:  17223392     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A sensitive liquid chromatographic method for the analysis of clarithromycin, a macrolide antibiotic, in human serum using pre-column derivatization with 9-fluorenylmethyl chloroformate (FMOC-Cl) is described. The method involved liquid-liquid extraction of the drug and an internal standard (amantadine) followed by pre-column derivatization of the analytes with FMOC-Cl. A mixture of 0.05 M phosphate buffer containing triethylamine (2 mL L(-1); pH 3.8) and methanol (17:83, v/v) was used as mobile phase and chromatographic separation was achieved on a Shimpack CLC-ODS column. The eluate was monitored by a fluorescence detector with respective excitation and emission wavelengths of 265 and 315 nm. The analytical method was linear over the concentration range of 0.025-10 microg mL(-1) of clarithromycin in human serum with a limit of quantification of 0.025 microg mL(-1). The assay is sensitive enough to measure drug levels obtained in human single dose studies. In the present method, sensitivity and run time of analysis have been improved, and successfully applied in a bioequivalence study of three different clarithromycin preparations in 12 healthy volunteers.
Authors:
Gholamreza Bahrami; Bahareh Mohammadi
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't; Validation Studies     Date:  2006-12-30
Journal Detail:
Title:  Journal of chromatography. B, Analytical technologies in the biomedical and life sciences     Volume:  850     ISSN:  1570-0232     ISO Abbreviation:  J. Chromatogr. B Analyt. Technol. Biomed. Life Sci.     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-04-30     Completed Date:  2007-07-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101139554     Medline TA:  J Chromatogr B Analyt Technol Biomed Life Sci     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  417-22     Citation Subset:  IM    
Affiliation:
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran. gbahrami@kums.ac.ir
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MeSH Terms
Descriptor/Qualifier:
Anti-Bacterial Agents / blood*,  pharmacokinetics
Chromatography, High Pressure Liquid / methods*
Clarithromycin / blood*,  pharmacokinetics
Fluorenes / chemistry*
Humans
Sensitivity and Specificity
Spectrometry, Fluorescence
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; 0/Fluorenes; 28920-43-6/1-(9-fluorenyl)methyl chloroformate; 81103-11-9/Clarithromycin

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


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