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

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posted on 2023-04-14, 14:04 authored by Zhenqing Zhang, Xing Yang, Lu Zhang, Haizhong Zhu, Biao Huang, Qian Chen, Yijun Wang, Chen Yu, Luke Bi, Meiyu Geng, Liang Li

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.


L Li was an employee of Green Valley (Shanghai) Pharmaceuticals Co. Ltd. This work was supported by the Shanghai Municipal Science and Technology Major Project and the Priority Academic Program Development of the Jiangsu Higher Education Institutes (PAPD).