Abstract

A sensitive LC–MS method was developed and validated for the determination of niflumic acid (NFA), the active metabolite of the talniflumate formulation, in human plasma. The analyses were performed on C 18 column using acetonitrile–ammonium acetate buffer (pH 5.7, 40:60) as a mobile phase with quadrupole MS detection of NFA at m/ z 281 in a negative ion-monitoring mode. Calibration curve was linear in the concentration range of 1–1000 ng/mL in human plasma. The higher sensitivity of LC–MS allowed low concentrations of NFA to be determined at initial drug absorption and terminal elimination phases following oral administration of talniflumate tablet.

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