Determination of subasumstat in human urine using LC-MS/MS
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Updated: Oct 31, 2026
Integration of Miniaturized Solid Phase Extraction and LC-MS/MS Detection of 3-Nitrotyrosine in Human Urine for Clinical Applications
Published on: July 14, 2017
Feng Yin1, Ran Ye1, Anson Pierce1
1Quantitative Pharmacology & Translational Sciences, Takeda Development Center Americas, Inc., Cambridge, MA, USA.
Aim:
TAK-981 (Subasumstat) inhibits cancer cell growth and promotes the production of type I interferons (IFN-Is). It is crucial to establish a reliable bioanalytical assay to measure TAK-981 levels in human urine for its clinical evaluation in oncology drug development.
Materials And Methods:
TAK-981 was quantitated by LC-MS/MS assay with its stable isotope labelled internal standard TAK-981-13C4, 15N2. Samples were extracted from human urine containing 0.05% tween 20 with ACN and analyzed on an ACQUITY HSS T3 column.
Results:
This assay was validated under regulatory guidance over a concentration range of 10 ng/mL to 2500 ng/mL and has been implemented to support clinical studies. Across all QC concentrations, the inter-run %RE ranged from -2.1% to 2.3% with %CV ranged from 2.3% to 3.0%.
Conclusion:
To our knowledge, this is the first published LC-MS/MS assay validated for the quantitation of TAK-981 in human urine.
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