A New Solid-Phase Extraction Method for Determination of Pantoprazole in Human Plasma Using High-Performance Liquid
Dragica Zendelovska1, Emilija Atanasovska1, Kalina Gjorgjievska1
1Institute of Preclinical and Clinical Pharmacology and Toxicology, Medical Faculty, Ss. Cyril and Methodius University of Skopje, 50 Divizija 6, 1000 Skopje, Republic of Macedonia.
A new high-performance liquid chromatographic (HPLC) method with solid-phase extraction accurately determines pantoprazole in human plasma. This validated method is suitable for pharmacokinetic and bioequivalence studies.
Area of Science:
- Analytical Chemistry
- Pharmacokinetics
- Bioanalysis
Background:
- Development of a simple, selective, and accurate high-performance liquid chromatographic (HPLC) method for pantoprazole determination in human plasma.
- Utilizes solid-phase extraction for efficient sample preparation.
Purpose of the Study:
- To develop a new HPLC method for quantifying pantoprazole in plasma samples.
- To enable simple, rapid isolation and concentration of pantoprazole.
Main Methods:
- Chromatographic separation on a LiChroCart LiChrospher 60 RP select B column.
- Mobile phase: 0.2% triethylamine in water and acetonitrile (58:42).
- Solid-phase extraction using LiChrolut RP-18, with optimized buffering and elution steps.
Main Results:
- Excellent linearity (R² > 0.996) in the range of 25.0-4000.0 ng/mL.
- Pantoprazole and lansoprazole retention times of 4.1 and 6.0 min, respectively.
- Limit of quantification at 25.0 ng/mL with good intra- and inter-day precision (RSD 4.2-9.3%).
Conclusions:
- The developed HPLC method demonstrates good precision and accuracy.
- Successfully applied to pharmacokinetic and bioequivalence studies of 40 mg pantoprazole in healthy volunteers.
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