Rapid and sensitive bioanalytical method for measurement of fluvoxamine in human serum using 4-chloro-7-nitrobenzofurazan as pre-column derivatization agent: application to a human pharmacokinetic study.
A sensitive and rapid high-performance liquid chromatographic method for the analysis of fluvoxamine, a selective serotonin reuptake inhibitor in human serum, is described using 4-chloro-7-nitrobenzofurazan as pre-column derivatization agent. The drug and an internal standard (fluoxetine) were extracted from 0.25 mL of serum using ethyl acetate as extracting solvent and subjected to pre-column derivatization by the reagent. A mobile phase consisting of methanol and sodium phosphate buffer (0.05 M; pH 2.8) containing 1 mL/L triethylamine (72:28 v/v) was used and chromatographic separation was performed on a Shimpack CLC-C18 (150 mm x 4.6mm) column. The fluorescence derivatives of the drugs were monitored at excitation and emission wavelengths of 470 and 537 nm, respectively. The calibration curve was linear over the concentration range of 0.5-240 ng/mL with a limit of quantification (LOQ) of 0.5 ng/mL using 0.25 mL serum sample. The method validation was performed for its selectivity, specificity, sensitivity, precision and accuracy. In this method, which was applied in a randomized cross-over bioequivalence study of two different fluvoxamine preparations in 24 healthy volunteers, the sensitivity and run time of analysis were significantly improved.
Bahrami
Gholamreza
G
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran. gbahrami@kums.ac.ir
Mohammadi
Bahareh
B
D009327:4-Chloro-7-nitrobenzofurazan / Q000737:chemistry*; D000284:Administration, Oral; D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics* / Q000494:pharmacology; D001681:Biological Assay / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D016666:Fluvoxamine / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics* / Q000494:pharmacology; D006801:Humans; D008297:Male; D012680:Sensitivity and Specificity; D013997:Time Factors
D014151:Anti-Anxiety Agents; D009327:4-Chloro-7-nitrobenzofurazan; D016666:Fluvoxamine