High-performance liquid chromatographic analysis of griseofulvin in drug substance and solid dosage forms: separation of impurities and metabolites.

A high-performance liquid chromatographic (HPLC) system, consisting of a methanol-water (3:2 v/v) mobile phase and a Zorbax CN column with m-phenylphenol as the internal standard, was utilized to determine the purity of griseofulvin bulk drug substance, to assay griseofulvin in powders, tablets, capsules, and boluses, and to separate griseofulvin from its metabolites. The method was tested on commercial griseofulvin samples, griseofulvin tablets, and a mixture of griseofulvin and its metabolites. The HPLC method is compared to a GLC method.