HTC-15 - Abstract

Abstract Title: Chromatographic strategies combining RPLC, mixed-mode HPLC and SFC coupled to MS for impurity profiling of drugs candidates
Abstract Type: Seminar
Session Choice: Fundamentals in Separation Science (KVCV)
Presenter Name: Ms Elise Lemasson
Co-authors:Dr Sophie Bertin
Dr Philippe Hennig
Dr Eric Lesellier
Dr Caroline West
Company/Organisation: Institut de Chimie Organique et Analytique (ICOA)
Country: France

Abstract Information :

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 stationary phase with UV and MS detection remains the method of choice for impurity profiling of drug candidates. However, this method sometimes fails, particularly when the active pharmaceutical ingredient is not sufficiently retained on the column. It is essential to turn to alternative and complementary analytical methods.

This work deals with the development of alternative analytical methods to reversed-phase HPLC on C18 phase for impurity profiling of pharmaceuticals. Reversed-phase HPLC on other stationary phases (e.g. pentafluorophenyl phases), mixed-mode HPLC (combining reversed-phase and ion-exchange mechanisms) as well as SFC were explored. The chromatographic and detection performances of each technique to analyze pharmaceutical compounds was evaluated with a set of 140 pharmaceutical compounds from Servier Research laboratories. These performances were compared with those of reversed-phase HPLC on a conventional C18 stationary phase. The comparison and the study of the different methods allowed proposing an overall strategy of analysis for any new active ingredient.