Mitotane has been used for adrenal cancer and inoperable Cushing's syndrome. In a previous study, monitoring of the plasma mitotane level is important for assessments of efficacy and adverse drug reactions such as digestive symptoms.A simple and highly sensitive high-performance liquid chromatographic method was developed for the determination of mitotane in human plasma. Mitotane and 2,2-diphenylpropane as an internal standard were extracted from plasma with ethyl acetate. They were separated by a J'sphere ODS-H80 column with a mixture of methanol-acetonitrile-water (81:6:13, v/v/v) as a mobile phase, and were then detected with a UV detector at 210 nm. The within- and between-day variations for Mitotane were reliable. The method is very simple, rapid, sensitive and selective for mitotane, and may therefore be useful as a routine analysis for the therapeutic drug monitoring of mitotane.
