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

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 parametersmet 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.