SOLID-PHASE EXTRACTION AND HPLC DETERMINATIONOF NIMESULIDE AND ITS ACTIVE METABOLITE IN HUMAN BLOOD SERUM

摘要

A procedure for the rapid determination of nimesulide (N) and its active metabolite (Ml) [4'-ni-tro-2'-(4-hydroxyphenyloxyphenyl)methanesulfonamide] in human serum that includes solid-phase extraction with octylsilyl-silica gel followed by gradient reverse-phase HPLC with diode-array detection has been developed and validated. The ranges of linearity for the determination of Ml and N were 20.0 - 4,000.0 and 50.0 - 10,000.0 ng/mL, respectively; the limits of detection (3a), 13 and 10 ng/mL, respectively. Long-term stability of the analytes in biosamples and the stability of samples after the preparation procedure were 1 month and 48 h, respectively. The procedure was used for bioequivalence studies of drugs containing N.