Development and validation of LC–MS/MS method for quantitation of sodium oligomannate in human plasma, urine and feces

Abstract

Background: Sodium oligomannate was approved for marketing by the National Medical Products Administration of China in 2019 for improving cognitive functions in mild-to-moderate Alzheimer's disease patients. Method: LC–MS/MS methods were established and validated for the quantitation of sodium oligomannate in human plasma, urine and feces to support clinical development studies. Samples were prepared using liquid–liquid extraction and analyzed by ion-pair reversed-phase LC–MS/MS with calibration standard curve ranges of 25.0–5000 ng/ml, 0.500–100 μg/ml and 100–10,000 μg/g in plasma, urine and feces, respectively. Results & conclusion: All validation parameters met the respective acceptance criteria established by US FDA and International Council for Harmonisation of Technical Requirements for Human Use guidelines. The validated methods were applied to a pharmacokinetics and excretion study in healthy Chinese subjects.