Molar Mass Distribution of a Polymer-Drug Conjugate Containing the Antitumor Drug Paclitaxel by Size Exclusion Chromatography and Universal Calibration

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Abstract
The development of a Size Exclusion Chromatography (SEC) method for the characterization of the polymer-drug conjugate PNU 166945 is presented. PNU 166945 is a conjugate between poly[N-(2-hydroxypropyl) methacrylamide)] and the antitumor drug paclitaxel. This study follows a previous paper on a similar polymer conjugate, FCE 28068, containing the same polymeric carrier and the antitumor drug doxorubicin. The aim was an accurate and reproducible, yet relatively simple and rapid method for the routine quality control of production batches. Thirteen PNU 166945 narrow fractions were separated, by semi-preparative SEC, and characterized by on-line SEC-Viscometry and off-line Light Scattering. The fractions allowed us to verify that PNU 166945 follows the universal calibration constructed with PEO/PEG narrow standards. So a conventional SEC method that utilizes just a refractive index detector and universal calibration with commercial narrow standards was found suitable. The study also reports data on accuracy and reproducibility of the SEC measurement.