Abstract

A sensitive, cost-effective, reproducible high-performance liquid chromatography method was developed and validated for quantitative determination of acetaldehyde in candesartan cilexetil using the concept of threshold of toxicological concern. Acetaldehyde is reacted with 2,4-dinitrophenylhydrazine to form a Schiff base product with an absorbing maximum at 364 nm. Effective chromatographic separation was achieved on an Inertsil ODS 3V, 250×4.6 mm, 5 µm column with a mobile phase of 40:60 v/v water and acetonitrile and at a flow rate of 1.0 ml/min. The column temperature was controlled at 25° and the injection volume was 30 µl. These conditions resolved the dinitrophenylhydrazine-acetaldehyde product with unreacted dinitrophenylhydrazine, the drug substances and related impurities, as well as diluent peak within 20 min. The retention time of dinitrophenylhydrazine-acetaldehyde product was approximately 10.6 min. The method was linear, accurate, precise, specific, rapid and found suitable for this analysis.