Development of an achiral supercritical fluid chromatography method with ultraviolet absorbance and mass spectrometric detection for impurity profiling of drug candidates. Part I: Optimization of mobile phase composition

Development of an achiral supercritical fluid chromatography method with ultraviolet absorbance and mass spectrometric detection for impurity profiling of drug candidates. Part II. Selection of an orthogonal set of stationary phases

“…In designing this test set, the purpose was to have a set that would be as representative as possible of the diversity of chemical structures usually encountered in this pharmaceutical company [1]. The resulting group of analytes comprises acids, bases and neutrals, with log P values in the range [−2; 8.0].…”

“…In the first part of this study, focusing on mobile phase selection, a gradient elution with carbon dioxide and methanol comprising 2% water and 20 mM ammonium acetate proved to be the best in terms of chromatographic performance, while also providing good MS response [1].…”

“…Because the method aims at direct applicability in a pharmaceutical company, a large selection (160) of drug candidates provided by Servier Research Laboratories was evaluated. We finally settled our choice on a gradient elution of methanol comprising 2% water and 20 mM ammonium acetate [1]. The second part, described in the present paper, will focus on stationary phase selection to achieve orthogonal methods.…”

“…Supercritical fluid chromatography (SFC) is a very useful tool to achieve this objective, as an adequate selection of stationary phases can provide orthogonal separations so as to maximize the chances to see all impurities.In this series of papers, we have developed a method for achiral SFC-MS profiling of drug candidates, based on a selection of 160 analytes issued from Servier Research Laboratories.In the first part of this study, focusing on mobile phase selection, a gradient elution with carbon dioxide and methanol comprising 2% water and 20 mM ammonium acetate proved to be the best in terms of chromatographic performance, while also providing good MS response [1].The objective of this second part was the selection of an orthogonal set of ultra-high performance stationary phases, that was carried out in two steps. Firstly, a reduced set of analytes (20) was used to screen 23 columns.…”

A visual investigation of different pollutants on the rheological properties of sodium/potassium formate fluids

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