A Rapid High-performance Liquid Chromatographic Method for the Determination of Pantoprazole in Plasma Using UV Detection

Abstract

A rapid, sensitive and reproducible HPLC method was developed and validated for the analysis of pantoprazole (CAS 102625-70-7) in human plasma. The separation was achieved on a monolithic silica column using acetonitrile-potassium dihydrogen phosphate buffer (25:75,v/v), pH 3.0, as the mobile phase at a flow rate of 1.5 ml min⁻¹. The wavelength was set at 290 nm. The assay enables the measurement of pantoprazole for therapeutic drug monitoring with a minimum quantification limit of 20 ng ml⁻¹. The method involves a simple protein precipitation procedure. Analytical recovery was complete. The calibration curve was linear over the concentration range 20–3500 ng ml⁻¹. The coefficients of variation for the inter-day and intra-day assay were found to be less than 7%.

Key words

CAS 102625-70-7 - Pantoprazole, determination in plasma, HPLC-UV, pharmacokinetic studies - Proton pump inhibitors

• References

• 1 Cheer SM, Prakash A, Faulds D, Lamb HM. Pantoprazole: an update of its pharmacological properties and therapeutic use in the management of acid-related disorders. Drugs. 2003; 63: 101-133
• 2 Radhofer-Weite S. Pharmacokinetics and metabolism of the proton pump inhibitor pantoprazole in man. Drugs Today. 1999; 35: 765-772
• 3 Sachs G, Shin JM, Briving C, Wallmark B, Hersey S. The pharmacology of the gastric acid pump: the H+,K+ ATPase. Annu Rev Pharmacol Toxicol. 1995; 35: 277-305
• 4 Ramakrishna NV, Vishwottam KN, Wishu S, Koteshwara M. High-performance liquid chromatography method for the quantification of entacapone in human plasma. J Chro-matogr B. 2005; 822: 326-329
• 5 Cass QB, Degani AL, Cassiano NM, Pedrazoli J. Enantiomeric determination of pantoprazole in human plasma by multidimensional high-performance liquid chromatography. J Chromatogr B. 2005; 766: 153-60
• 6 Tanaka M, Yamazaki H. Direct determination of pantoprazole enantiomers in human serum by reversed-phase high-performance liquid chromatography using a cellulose-based chiral stationary phase and column-switching system as a sample cleanup procedure. Anal Chem. 1996; 68: 1513-1516
• 7 Huber R, Muller W, Banks MC, Rogers SJ, Norwood PC, Doyle E. High-performance liquid chromatographic determination of the H[+]/K[+] ATPase inhibitor (BY 1023/SK&F 96 022) and its sulphone metabolite in serum or plasma by direct injection and fully automated pre-column sample clean-up. J Chromatogr. 1990; 529: 389-401
• 8 Peres O, Oliveira CH, Barrientos-Astigarraga RE, Rezende VM, Mendes GD, de Nucci G. Determination of Pantoprazole in Human Plasma by LC-MS-MS Using Lansoprazole as Internal Standard. Arzneimittel-Forschung (Drug Research). 2004; 54: 314-319
• 9 Pue MA, Laroche J, Meineke I, de Mey C. Pharmacokinetics of pantoperazole following single interavenous and oral administration to healthy male. Eur J Clin Pharmacol. 1993; 44: 575-578