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High-performance liquid chromatography method for the quantification of pantoprazole in human plasma
N V S Ramakrishna1, K N Vishwottam, S Wishu
1Biopharmaceutical Research, Suven Life Sciences Ltd., Serene Chambers, Banjara Hills, Hyderabad 500034, India. nvsrk@suven.com
Summary
A new HPLC method accurately quantifies pantoprazole (a proton-pump inhibitor) in human plasma. This validated assay is sensitive and repeatable, suitable for pharmacokinetic research.
Area of Science:
- Analytical Chemistry
- Pharmacology
Background:
- Pantoprazole is a widely used proton-pump inhibitor.
- Accurate quantification of pantoprazole in biological matrices is crucial for pharmacokinetic studies.
Purpose of the Study:
- To develop and validate a sensitive and selective High-Performance Liquid Chromatography (HPLC) method for the quantification of pantoprazole in human plasma.
Main Methods:
- Development of a single-step liquid-liquid extraction using methyl tert-butyl ether/diethyl ether.
- Separation of pantoprazole and zonisamide (internal standard) on a Waters symmetry C18 column with an isocratic mobile phase (10mM phosphate buffer/acetonitrile).
- UV detection at 290 nm.
Main Results:
- The method demonstrated a lower limit of quantification of 20 ng/mL with a relative standard deviation < 4%.
- A linear range of 20-5000 ng/mL was established.
- Excellent within-batch and between-batch precision (0.7-3.3% and 1.3-3.2%) and acceptable bias (-2.5 to 12.1% and -0.5 to 8.2%) were achieved.
Conclusions:
- The developed HPLC method is sensitive, selective, and repeatable.
- This validated method is suitable for determining pantoprazole concentrations in human plasma for pharmacokinetic studies.