Untargeted Analysis of Colored Impurities in Small Molecule Drug Tablets Formulation Development

摘要

The color inducing compounds in the small molecule drug tablets were hydrophobic compounds that were soluble in either organic acid or organic base. A moderately polar HPLC column is most suitable for analysis of the color-inducing compounds. MZmine2 is a powerful data processing tool that allows the user to detect non-detected peaks. Four possible features were extracted for further investigation. Structural characterization of four potential impurities have been performed by accurate MS, MS~n. Fraction of peaks of interest from LC will be collected, and confirm the structures by NMR. Relationship between the excipients compositions and impurity formation will be explored.