Особенности выбора операций подготовки проб плазмы крови для хроматографического анализа лекарственных препаратов
Аннотация
Метод обращенно-фазовой высокоэффективной жидкостной хроматографии (ОФ ВЭЖХ) со спектрофотометрическим/масс-спектрометрическим детектированием широко применяется для определения лекарственных соединений (ЛС) при проведении исследований фармакокинетики и для оценки биоэквивалентности ЛС. Растущее многообразие структур ЛС обусловливает сложность разработки биоаналитических методик определения содержания ЛС в биологических матрицах. Чаще всего встречающейся в практической работе матрицей является плазма крови человека, которая имеет сложный состав эндогенных веществ. Выбор и оптимизацию операций подготовки проб (или их сочетаний) до настоящего времени чаще всего проводят на основании самых общих представлений о природе определяемых соединений. Это приводит к большим затратам времени, которые удалось бы минимизировать, если связать характер операций подготовки проб с физико-химическими характеристиками аналитов.
В настоящей работе в результате систематизации известных способов подготовки образцов плазмы крови для определения ЛС рассмотрена возможность выбора таких способов на основании некоторых физико-химических свойств и биохимических характеристик целевых аналитов, прежде всего их факторов гидрофобности, степени связывания с белками плазмы и растворимости в воде.На основании сопоставления оригинальных экспериментальных и литературных данных описан подход к выбору способа подготовки проб для определения целевого аналита в плазме крови на основе свойств (фактор гидрофобности logP и степень связывания с белками плазмы) определяемого соединения.
Показано, что депротеинизация образцов при помощи ультрацентрифужных фильтров возможна только для тех соединений, степень связывания с белками которых ориентировочно не выше 50%. Значение logP определяет возможность применения распределительного варианта жидкостно-жидкостной экстракции в качестве способа подготовки образцов. При этом на выбор операции осаждения белков значения фактора гидрофобности не влияют, то есть данный способ подготовки проб является одинаково пригодным для липофильных и гидрофильных аналитов.
Выявленные особенности процедур подготовки проб плазмы крови для проведения хроматографического анализа позволяют оптимизировать процесс разработки и валидации биоаналитических методик, используемых при проведении клинических исследований.
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Литература
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