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.
Rossini
M L
ML
Galenical Research and Development, Farmitalia Carlo Erba, Milan, Italy.
Farina
M
M
D000970:Antineoplastic Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004304:Dosage Forms; D004317:Doxorubicin / Q000031:analogs & derivatives* / Q000032:analysis; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D013056:Spectrophotometry, Ultraviolet; D013696:Temperature
D000970:Antineoplastic Agents; D004304:Dosage Forms; C066998:methoxy-morpholinyl-doxorubicin; D004317:Doxorubicin