HPLC and LCMS/MS based chromatographic screening method impurities of Daprodustat with degradation kinetics, characterization and in silico toxicity

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The study identifies the degradation kinetics and impurities of daprodustat, emphasizing its safety profile and regulatory compliance.
Significant degradation occurred under stress conditions, and impurities were characterized using LC-MS/MS, revealing three primary degradation products.
A novel HPLC method was developed for sensitive analyses, with specific detection limits of 0.033 μg/mL for daprodustat and 0.075 μg/mL for impurities.
This research supports the quality control of daprodustat, showcasing a unified approach for impurity profiling, degradation testing, and toxicity analysis.

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This analysis demonstrates impurity profiling and degradation kinetics of daprodustat, highlighting its potential toxicity risks.

Kumar et al. (2025) studied this question.

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