Разработка методов контроля качества препарата мерафлам в капсулах

Abstract

Для комбинированного лекарственного препарата в форме капсул с фламином и орнидазолом «Мерафлам» предложена методика количественного определения орнидазола для проведения тестов «Количественное определение», «Растворение» и «Идентификация» методом жидкостной хроматографии. Была осуществлена валидация методики по основным валидационным характеристикам. Составлена спецификация для контроля качества препарата «Мерафлам».

For the combined drug Meraflam capsules containing flamin and ornidazole, the authors propose an ornidazole assay rocedure to carry out the tests «Assay», «Dissolution», and «Identification» by liquid chromatography using a 250×4.6-mm chromatographic column packed with octadecyl silica gel (C18) with 5-μm particles (column temperature, 25°C; detection at 310 nm). The following solvent mixture: methan ol/water (20:80) adjusted to pH 4.0 with phosphoric acid at a flow rate of 1.0 ml/min was optimal as the mobile phase. According to the requirements of the State Pharmacopoeia of Ukraine, the assay procedure for ornidazole capsules (B) was validated by the main validation haracteristics: specificity, linearity, precision (convergence), accuracy, and range of usability. Since the ornidazole tolerance in the drug product at the moment of its production were established within +5%; during validation, the criteria for assessing this procedure were parameters for B = 5.0%, i.e. the maximal assay uncertainty(∆As) should not be greater than 1.6%. The obtained validation characteristics completely meet the acceptability criteria by all va lidation parameters. A specification was compiled to control meraflam quality, which included the following sections: «Description», «Identification», «Average mass of the content of capsules», «Uniformity of mass», «Disintegration», «Dissolution», «Microbiological purity», and «Assay».