Determination of esomeprazole in human plasma by UPLC-MS/MS and its bioequivalence study in healthy Chinese subjects
Objective To established and validated a UPLC-MS/MS method for the determination of esomeprazole in human plasma,which was applied to bioequivalence study.Methods UPLC-MS/MS method using esomeprazole-d3 as the internal standard(IS)was used to determine esomeprazole in human plasma.The determination was performed on ACE 3 C18-AR(50 mm × 2.1 mm,3 μm)with a linear gradient,the flow rate was 0.6 mL·min-1.The mobile phase A consisted of water containing 5 mmol·L-1 ammonium acetate,the mobile phase B consisted of acetonitrile.The ion transitions under multiple reaction monitoring(MRM)mode by ESI+ionization were performed at m/z 346.1→198.1 and m/z 349.1→198.1 for carbamazepin and esomeprazole-d3.The established method was used to determine the concentration of esomeprazole in human plasma in the bioequivalence study.Results The liner range of esomeprazole were 3-3 000 ng·mL-1(r ≥ 0.999 4).The intra-day and inter-day accuracies and precisions,the recoveries and matrix effects,and the sample stability were all suitable to the biological samples determination.The method was applied to determine human plasma samples of bioequivalence study,and it was proved that the test preparation and the reference preparation were bioequivalent.Conclusion The method was proved to be highly accurate,sensitive,selective,and suitable for the bioequivalence study of esomeprazole in healthy Chinese volunteers after a single oral dose of 40 mg esomeprazole suspension.The test preparation and the reference preparation were bioequivalent.
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