Application of preparative chromatography to the isolation of epirubicin from raw product

Epirubicin (4'-epidoxorubicin) has been found to be useful in the treatment of cancer. The isolation of milligram amounts of epirubicin from raw product was performed by reversed-phase high-performance liquid chromatography (R-P-HPLC) on Kromasil KR100- 10C(18) (250 x 4.6 mm I.D., 10 mum) column. The purity of epirubicin is required to be greater than 99%. First, is adjusting the mobile phase composition, the column temperature, and the flow-rate to increase the separation factor between the desired component and the nearest neighbor. Then, it is possible to increase the column efficiency and to reduce the time of separation required. Besides, displacement effects could be utilized efficiently to increase the sample size and, therefore, the production rate. The location of the cut points for the collection of target compound was determined by use of detector response levels. This method can be used as a guide to scale up the industrially preparative separation of epirubicin.