Abstract
Cytostasan, 5-[Bis(2-chloroethyl)amino]-1-methylbenzimidazolyl-2-butyric acid, is an antineoplastic agent which degrades spontaneously in water solutions yielding two hydrolysis products, monohydroxy- and dihydroxycytostasan. We developed a stability-indicating radiochemical assay based on ion-pair extraction to investigate the stability of solutions of14C-cytostasan under conditions that might be expected when the drug is being prepared and stored for pharmacokinetic studies in animals. The possibility of using the distribution coefficient of14C-cytostasan as an indicator of stability was investigated in the extraction system benzene-dicarbolide of cobalt-0.5N HClO4. The mechanism of extraction is believed to be that of ion-pair forming process between the hydrophobic anion and the protonized cytostasan. Since no extraction of hydroxy derivates was observed the value of the distribution coefficient of the parent drug appears to be a suitable indicator of the stability of14C-cytostasan solutions.
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