Chromatographia

, Volume 67, Issue 9–10, pp 795–799 | Cite as

LC Determination and Bioequivalence Study of Pantoprazole in Human Plasma

  • Honggang Lou
  • Hong Yuan
  • Zourong Ruan
  • Donghang Xu
  • Quan Zhou
Full Short Communication

Abstract

A selective and sensitive liquid chromatography (LC) method with rapid sample processing was developed for determination of pantoprazole in human plasma using omeprazole as internal standard (IS). The plasma sample (100 μL) was deproteined by precipitation with methanol. The supernatant was directly determined by LC using a Diamonsil C18 ODS column and solution of 10 mM Na2HPO4 buffer (containing 0.01% H3PO4) and acetonitrile (68:32, v/v, pH = 6.8) as mobile phase with UV detector set at 288 nm. The retention time of IS and pantoprazole were 4.9 ± 0.2 and 5.6 ± 0.2 min, respectively. The method was validated with a linear range of 0.03–5.0 μg mL−1 and the lowest limit of quantification was 0.03 μg mL−1 for pantoprazole (r = 0.9999). The coefficient of variation for intra-day and inter-day accuracy and precision was less than 9.5%. The mean extraction recovery was 84.1%. Quality control samples were stable when kept at autosampler temperature for 24 h, at −20 °C for 42 days and after three freeze-thaw cycles. The assay was successfully applied to a randomized, two-period cross-over bioequivalence study in 20 healthy Chinese volunteers following a single oral dose of 40 mg pantoprazole. Various pharmacokinetic parameters including AUC 0∼t , AUC 0∼∞, C max, T max and t 1/2 were determined from plasma concentration of both formulations. The results indicated that the analytical method was a specific, precise, sensitive and rapid procedure for determination of plasma pantoprazole concentration and therefore, a suitable and valuable tool in the investigation of the clinical pharmacokinetics and bioequivalence.

Keywords

Column liquid chromatography Pharmacokinetics study Bioequivalence Pantoprazole 

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Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2008

Authors and Affiliations

  • Honggang Lou
    • 1
  • Hong Yuan
    • 1
  • Zourong Ruan
    • 1
  • Donghang Xu
    • 1
  • Quan Zhou
    • 1
  1. 1.Division of Clinical Pharmacology, the 2nd Affiliated Hospital, School of MedicineZhejiang UniversityHangzhouPeople’s Republic of China

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