QUANTIFICATION OF PANTOPRAZOLE BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) METHOD: IN VITRO AND IN VIVO APPLICATIONS

Abstract

A simple, sensitive, and selective HPLC method with UV detection was developed and validated for quantitation of pantoprazole in enteric coated tablets, dissolution medium, and human plasma following simple liquid–liquid extraction. The separation was achieved on a μ-Bondapak C₁₈ HPLC column using sodium hydrogen phosphate solution (0.01 M)/acetonitrile (60/40 v/v) at pH 7.4 ± 0.1, as the mobile phase at a flow rate of 1.5 mL/min. Omeprazole was used as the internal standard for analysis of plasma samples. The retention time for pantoprazole and omeprazole were 8.4 and 7 min, respectively. Calibration curve was linear in the range of 0.025–5 µg/mL of pantoprazole using human plasma with the average recovery of 85 ± 5%. Within-day and between-day precision and accuracy did not exceed 14.4% and 15.8%, respectively. The HPLC assay was performed isocratically on a reversed-phase column with UV detection. A limit of quantification of 25 ng/mL achieved in our study was approximately twenty times smaller than that of other reported methods. The assay was applied to the analysis of pantoprazole levels in plasma collected from healthy participants entered to the pharmacokinetic study of this drug.

Keywords:

• bioavailability
• HPLC
• liquid–liquid extraction
• pantoprazole
• pharmacokinetics
• UV detector

Notes

^a Standard Deviation.

^b Coefficient of Variation.

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