ОПРЕДЕЛЕНИЕ ПОЛИСОРБАТОВ СПЕКТРОФОТОМЕТРИЧЕСКИМ МЕТОДОМ В ЛЕКАРСТВЕННЫХ ПРЕПАРАТАХ НА ОСНОВЕ РЕКОМБИНАНТНЫХ БЕЛКОВ

Разработана методика определения полисорбата-20 и полисорбата-80 в лекарственных препаратах на основе рекомбинантных белков методом спек трофотометрии. Выделение полисорбата из раствора проводится с помощью твердофазной экстракции с последующим элюированием полисорбата ацетонитрилом. Ацетонитрильный раствор упаривается, и полисорбат дериватизуется железотиоцианатным реагентом, полученный дериватизат извлекается в органическую фазу, и измеряется оптическая плотность. Подобраны наиболее оптимальные условия дериватизации, экстракции в органическую фазу и измерения полисорбата. Проведена валидация методики: определены её специфичность, линейность, правильность, прецизионность, устойчивость, предел количественного определения.

валидация, рекомбинантные белки, полисорбат, твердофазная экстракция, твин, тиоцианат железа

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