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Updated: Aug 2, 2025
A Strategy for Sensitive, Large Scale Quantitative Metabolomics
Published on: May 27, 2014
Development and validation of LC-MS/MS method for quantitation of sodium oligomannate in human plasma, urine and
Zhenqing Zhang1, Xing Yang2, Lu Zhang2
1Jiangsu Key Laboratory of Translational Research & Therapy for Neuro-Psycho-Diseases & College of Pharmaceutical Sciences, Soochow University, Suzhou, Jiangsu, 215021, China.
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.
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