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Validated HPLC‐UV method for determination of naproxen in human plasma with proven selectivity against ibuprofen and paracetamol
Author(s) -
Filist Monika,
Szlaska Iwona,
Kaza Michał,
Pawiński Tomasz
Publication year - 2016
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.3635
Subject(s) - naproxen , chemistry , chromatography , ibuprofen , bioanalysis , bioequivalence , human plasma , high performance liquid chromatography , analyte , calibration curve , naproxen sodium , pharmacokinetics , matrix (chemical analysis) , detection limit , pharmacology , medicine , alternative medicine , pathology
Estimating the influence of interfering compounds present in the biological matrix on the determination of an analyte is one of the most important tasks during bioanalytical method development and validation. Interferences from endogenous components and, if necessary, from major metabolites as well as possible co‐administered medications should be evaluated during a selectivity test. This paper describes a simple, rapid and cost‐effective HPLC‐UV method for the determination of naproxen in human plasma in the presence of two other analgesics, ibuprofen and paracetamol. Sample preparation is based on a simple liquid–liquid extraction procedure with a short, 5 s mixing time. Fenoprofen, which is characterized by a similar structure and properties to naproxen, was first used as the internal standard. The calibration curve is linear in the concentration range of 0.5–80.0 µg/mL, which is suitable for pharmacokinetic studies following a single 220 mg oral dose of naproxen sodium. The method was fully validated according to international guidelines and was successfully applied in a bioequivalence study in humans. Copyright © 2015 John Wiley & Sons, Ltd.