Stability studies with a high-performance liquid chromatographic method for the determination of a new anthracycline analogue, 3'-deamino-3'-[2-(S)-methoxy-4-morpholino)doxorubicin (FCE 23762), in the final drug formulation.
A high-performance liquid chromatographic method was studied to optimize the separation of FCE 23762, a new antitumour agent, from both synthetic impurities and degradation products having very similar molecular structures. The main problems faced in the analytical method development using the most common reversed-phase columns available arose from the presence of analytical peaks with poor symmetry, a long analysis time and the separation between FCE 23762 and its R-isomer, which was often unsuitable for the correct determination of the drug substance. The use of a new stationary phase, Zorbax Rx-C8, together with a suitable mobile phase resulted in a good separation between the diastereomers, with satisfactory peak symmetry and run time. The method permitted the study of the stability of the drug substance in formulations for clinical trials.