摘要

A simple, rapid and sensitive ultra performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method is described for determination of omeprazole in human plasma samples using fluconazole as the internal standard (IS) from bioequivalence assays. Sample preparation was accomplished through protein precipitation with acetonitrile, and chromatographic separation was performed on an Acquity BEH C18 column (2.1 mm x 50 mm, 1.7 mu m) with gradient profile at a flow of 0.45 mL/min. Mass spectrometric analysis was performed using a QTrap5500 mass spectrometer coupled with an electro-spray ionization (ESI) source in the positive ion mode. The MRM transition of 346.2 -> 198.0 was used to quantify for omeprazole. The linearity of this method was found to be within the concentration range of 25-1500 ng/mL for omeprazole in human plasma. Only 1.5 min was needed for an analytical run. The method was applied to a bioequivalence study of two drug products containing omeprazole in human plasma samples, and allowed determination of omeprazole at low concentrations with a higher throughput than previously described methods.