Development of a reversed-phase ion-pairing liquid chromatographic assay of daunorubicin for pharmacopoeial use.

A liquid chromatographic method is described for the determination of daunorubicin using octyldecylsilyl columns and sodium dodecyl sulphate as ion-pairing agent. The method based on previous publication [M. A. van Lancker et. al., J. Chromatogr., 254 (1983) 45] is specific for daunoribicin and separates it from likely impurities, e.g., the aglycone, duborimycin and related anthracyclines, doxorubicin and epirubicin. Several commercial batches have been examined in a number of laboratories employing various types of stationary phases. The intralaboratory reproducibilities varied from 1.0 to 1.6% and the interlaboratory reproducibility between 0.63 and 1.0% (based on the means of duplicate determinations), while with the preferred mobile phase the coefficient of variation was 0.3% (n = 4). The method is robust and is proposed for inclusion in a monograph on daunorubicin which is currently under consideration by the European Pharmacopoeia.