Estimation of impurity profiles of drugs and related materials. Part 9: HPLC investigation of flumecinol.

Two HPLC systems have been developed for the investigation of flumecinol (3-trifluoromethyl-alpha-ethyl-benzhydrol). The reversed-phase system (LiChrosorb RP-18; methanol-water, 7:3, v/v) enables the isolation and identification of the impurities. The chiral system (Chiralcel OD; hexane-2-propanol, 98:2, v/v) separates the enantiomers of flumecinol and its impurities. The potential of spectral convolution in peak identification in HPLC impurity profiling is demonstrated by an example involving the identification of the 4'-methyl-analogue of flumecinol.