Molecular Characterization of Polymeric Antitumor Drug Carriers by Size Exclusion Chromatography and Universal Calibration

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Abstract
The development of a Size Exclusion Chromatography (SEC) method for the molecular characterization of FCE 28068, a conjugate between a synthetic polymeric carrier and the antitumor drug doxorubicin is presented. The aim was an accurate and reproducible, yet relatively simple and rapid method for the routine quality control of production batches. A standard SEC method that utilizes just a refractive index detector and relies upon universal calibration with commercial narrow standards was found suitable. The development of this method implied the following steps: test of universal calibration in the chosen experimental conditions with commercial narrow standards; fractionation of FCE 28068; test of compliance for the FCE 28068 fractions to universal calibration conditions; test of accuracy and reproducibility of the SEC measurement. The use of off-line light scattering and viscometry for the molecular characterization of standards and of FCE 28068 is discussed.