Validation of a Robust and High-Throughput HPLC-MS/MS Method to Determine Amantadine Levels in Human Plasma

Abstract

RESULTS: Lower limit of quantitation was validated to be 15 ng/mL with a reduced sample volume of 20 μL comparing with previously reported methods. Calibration curve was linear over a concentration range of 15-2000 ng/mL. In addition to linearity, other parameters including matrix selectivity, matrix effect, recovery, method accuracy and precision, sensitivity, and stabilities of amantadine under storage conditions were also fully validated following the guidance of United States Food and Drug Administration.