Possibilities and limitations of computer assisted chiral HPLC method development for ozanimod on polysaccharide based chiral stationary phases.

ABSTRACT: In this study, a direct HPLC method was developed to determine the enantiomeric purity of the immunomodulatory drug, ozanimod. A systematic method development process was followed, incorporating risk assessment, identification of critical analytical procedure parameters, initial screening of stationary phases, and software-assisted optimization of method parameters. Eight different polysaccharide-based chiral columns were selected to assess chiral separation of enantiomers under polar organic elution mode. The most promising results were obtained using a methanol:2-propanol mixture on the amylose-based Chiralpak AD column. Following this, systematic modeling was conducted using DryLab software to optimize method conditions, including isocratic eluent composition, temperature, and flow rate

SUBMITTER: Ferencz E 

PROVIDER: S-EPMC11538454 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature