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Stratégies chromatographiques en phase liquide et supercritique pour l'analyse de candidats médicaments

Abstract : Impurity profiling of drug candidates is a significant concern of pharmaceutical industries. The identification and quantification of impurities must be strictly controlled to ensure the efficacy and limited toxicity of the active ingredient. It is therefore necessary to have efficient analytical methods to ensure that all impurities are identified. Today, reversed-phase HPLC with C18 column remains the method of choice for this task. However, this method sometimes fails, particularly when the active pharmaceutical ingredient is not sufficiently retained on the column or when the impurities are not resolved from the main compound. It is therefore essential to turn to alternative and complementary analytical methods.This work deals with the development and evaluation of alternative analytical methods to reversed-phase HPLC on C18 phase for impurity profiling of pharmaceuticals. Reversed-phase HPLC on other stationary phases, mixed-mode HPLC as well as SFC were explored and their chromatographic performances compared. The comparison and the study of the different methods allowed proposing a strategy of analysis of the drug candidate.
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Submitted on : Wednesday, December 12, 2018 - 3:52:26 PM
Last modification on : Thursday, August 22, 2019 - 1:20:11 AM
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  • HAL Id : tel-01953059, version 1



Elise Lemasson. Stratégies chromatographiques en phase liquide et supercritique pour l'analyse de candidats médicaments. Autre. Université d'Orléans, 2018. Français. ⟨NNT : 2018ORLE2005⟩. ⟨tel-01953059⟩



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