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Aceclofenac, a nonsteroidal antiinflammatory agent of a phenylacetic acid type, has been used for rheumatoid arthritis and osteoarthritis. Although the metabolic pathway of aceclofenac is relatively well-known in vitro, pharmacokinetic profiles of its three major metabolites are still unclear in human. The present study was designed to investigate pharmacokinetic
profiles of the metabolites of aceclofenac, and to evaluate the bioequivalence of the generic preparation of aceclofenac 100 mg tablet. Blood samples were serially collected for a period of 12 hours following a single oral
administration of 100 mg aceclofenac in 20 healthy human volunteers. A simple protein precipitation with acetonitrile was employed to purify those substances from plasma. Aceclofenac, diclofenac, 4'-hydroxyaceclofenac and 4'-hydroxydiclofenac in heparinized plasma were simultaneously measured with flufenamic acid, an internal standard, using HPLC
coupled to a tandem mass spectrometer. Time courses of 4’-hydroxydiclofenac, diclofenac and aceclofenac plasma concentrations
were clearly revealed, and the pharmacokinetic properties were analyzed. The 90% confidence intervals for the ratios of test/reference for log-transformed AUC and Cmax lie within 0.80-1.25.
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