A feasibility study on direct assay of an aqueous formulation by chiral supercritical fluid chromatography (SFC)

Validation of direct assay of an aqueous formulation of a drug compound AZY by chiral supercritical fluid chromatography (SFC)

“…The DL was determined to be 1.5 g/ml and the identification limit (IL) at six times the s/n ratio was 3.0 g/ml. The DL and QL achieved here were comparable with those obtained for direct assay of a formulation of a basic compound in a previous work [20]. This demonstrated the direct assay technique offered similar sensitivity for both basic [20] and acidic (present work) compounds in neat aqueous formulations.…”

“…The DL and QL achieved here were comparable with those obtained for direct assay of a formulation of a basic compound in a previous work [20]. This demonstrated the direct assay technique offered similar sensitivity for both basic [20] and acidic (present work) compounds in neat aqueous formulations. Table 10 list the results obtained with the robustness testing for mobile phase flow rate and % composition of the modifier.…”

“…In a previous work, the applicability of SFC in neat aqueous formulation assay of a basic drug candidate was demonstrated with great success without any sample pretreatment and with ethanol/CO 2 mobile phase [20]. The goal of the present work was to further extend the application of this direct assay technique for an acidic drug prepared with an aqueous formulation vehicle.…”

Supercritical Fluid Chromatography

“…The direct assay of research compounds in 100% aqueous formulations by chiral SFC was reported by Mukherjee et al (Mukherjee and Cook, 2006 ;Mukherjee, 2007 ). These feasibility studies indiand/or toxicity.…”

Improving sensitivity in chiral supercritical fluid chromatography for analysis of active pharmaceutical ingredients

“…2,3 As a result, chiral chromatography has become an important analytical tool in modern drug development, with chiral supercritical fluid chromatography (SFC) emerging as a preferred technique for enantiopurity analysis to support development research. [4][5][6][7][8][9][10][11] In SFC, pressurized carbon dioxide replaces the organic solvents typically employed in chiral HPLC analysis.…”