HPLC determination of a new anticancer agent (acylfulvene) in serum.

High performance liquid chromatography (HPLC) combined with effective preseparation steps (liquid extraction, solid-phase extraction, preconcentration procedures) was used in pharmacokinetic studies of a novel anticancer agent (acylfulvene) in serum. HPLC conditions were optimized for the analysis of model clinical samples and real serum samples with different contents of acylfulvene. Extraction recoveries for both extraction procedures were evaluated and linearity was achieved for a wide concentration range. Detection limit for acylfulvene in serum was 0.075 microgram/ml, preconcentration minimum 5 times was recommended, especially after the solid-phase extraction step. The HPLC assay was applied for pharmacokinetic studies of acylfulvene in dogs and rats and pharmacokinetic parameters were determined.