LC-MS/MS determination of pantoprazole in human plasma and its application / 中国药学杂志

ABSTRACT

OBJECTIVE: To develop an LC-MS/MS method with direct precipitation of sample protein to determine the concentration of pantoprazole in human plasma. METHODS: LC-MS/MS equipment with ESI source and WATERS XTerra® RP18 (4.6 mm × 100 mm, 3.5 μm) column were used in the experiment. The column temperature was set at 35°C, 5 mmol · L-1 ammonium acetate-acetonitrile (4060, V/V) was used as mobile phase and the flow rate was 1.0 mL · min-1. The injection volume was 2 μL. Omeprazole was taken as the internal standard. Pantoprazole and omeprazole were detected with proton adducts at m/z 384.1 → 200.1 and m/z 346.1 → 198.0 in multiple reaction monitoring (MRM) positive mode, respectively. RESULTS: The calibration curve of pantoprazole was linear in the range of 5-6000 ng · mL-1 (r > 0.9900). The intra-day and inter-day relative standard deviations were both less than 6.5%, and the relative errors were within ±7%. The mean extract recoveries were more than 98%. In the stability studies, pantoprazole was found to be stable in plasma under various storage conditions. CONCLUSION: The method is rapid, simple, accurate, selective, and reproducible for the determination of pantoprazole in human plasma. The method is successfully applied to a pharmacokinetics study of pantoprazole sodium enteric-coated tablets in healthy volunteers.