Elution behavior of insulin on high-performance size exclusion chromatography at neutral pH
作者： Ruedeeporn Tantipolphan , Stefan Romeijn , John den Engelsman , Riccardo Torosantucci , Tue Rasmussen
DOI: 10.1016/J.JPBA.2010.01.014
关键词:
摘要: Abstract The pharmacopoeia protocol for HP-SEC of insulin, using an acidic non-physiological eluent, does not represent insulin's association state in the formulation. This study aimed to evaluate elution behavior a “physiological” (aqueous, neutral pH) on-line UV absorption and multi-angle laser light scattering detection. effect insulin concentration formulation (monitored by circular dichroism) eluent composition (zinc ion, arginine) on its was assessed. We showed that is affected both dynamic association–dissociation molecules insulin–column interactions. Insulin re-equilibrated making practically insensitive Zinc ions promoted hexamers, whereas arginine overruled zinc induced on-column dissociation dimers monomers. Combined results from compendial were shown provide better view aggregation heat-stressed than either single methods. insights obtained with this are crucial proper evaluation data insulin.
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