Establishing column batch repeatability according to Quality by Design (QbD) principles using modeling software.

Journal of Pharmaceutical and Biomedical Analysis(2015)

引用 15|浏览7
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摘要
•Twelve columns from the same brand name, but different batches were compared.•3D design of experiment was used for comparing column selectivity and performance.•3D resolution space allows establishing better method robustness before validation.•A multivariable design space (MODR) allows flexible routine work with columns.•This procedure allows easy column replacement to retain method robustness.
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关键词
DOE,DryLab,QbD,Robustness,UPLC-column comparison
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