Process Development and Optimization of Linagliptin Aided by the Design of Experiments (DoE)
ORGANIC PROCESS RESEARCH & DEVELOPMENT(2022)
摘要
A design of experiments (DoE) approach was applied to the development and optimization of the manufacturing process to prepare linagliptin. DoE techniques such as a central composite face-centered design and a fractional factorial design were applied to obtain the critical process parameters and establish the optimal reaction conditions. With process-related impurities determined and successfully removed, a robust high-yielding and high-purity procedure was identified, which has been successfully demonstrated at a 100 g scale level to prepare the desired product in a 68% overall isolated yield and high-performance liquid chromatography (HPLC) purity of around 99.9%.
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关键词
linagliptin,process optimization,DoE,impurity control
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