Neutral Drug: Mobile phase and column for fed state biorelevant media

NEW! Analysis

Typically, for a neutral drug molecule analysed in fed-state medium, a mobile phase consisting of methanol and ammonium carbonate buffer at pH 7.0 provides good chromatographic performance. This type of mobile phase is commonly used with a C18 column, for example with a particle size of 3 µm or 5 µm, a length of 150 mm, and an internal diameter of 4.6 mm.

Pharmacopeial monograph methods or validated QC HPLC methods may also be used, provided that the mobile phase is compatible with fed-state medium.

Mobile phases containing acetonitrile should not typically be used for analysing drug content in fed-state samples, as ACN may cause precipitation of fed-state components in the HPLC column.

This can lead to column fouling, variable recovery, altered peak shape, and shifts in drug retention time. Methanol can typically be substituted for ACN in most mobile phases.