Objective:To develop an HPLC
method for the study of
pharmacokinetics and
bioavailability of two
omeprazole formulations in human body Methods:After adding the internal standard nimesulide,the
plasma samples were extracted with ethyl ether and
determined by HPLC Chromatography was performed on a Hypersil ODS2 column(20 cm×4 6 mm,5 μm)with methanol-water-acetic acid-triethylamine(60∶40∶0 5∶0 5)as the mobile phase The flow rate of mobile phase was 1 mL·min -1 The detection wavelength was 302 nm The plasma concentration of omeprazole was determined by this HPLC method following a single oral dose of 40 mg of two omeprazole formulations given to each 12 volunteers in an open randomized two-way crossover design Results:The extraction recovery of this method ranged from 87 02% to 98 07% The concentration detection limit of omeprazole in human plasma was 3 ng·mL -1 The linear range was from 5～1 800 ng·mL -1 The pharmacokinetics and relative bioavailability of the two formulations were determined by this method Conclusion:The established HPLC method was proved to be a good method for the determination of omeprazole in human plasma The plasma concentration-time curve of two formulations conformed to one compartment model and the bioavailability results of two formulations were similar
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