Фотогенерированный йод для определения активных фармацевтических ингредиентов препарата «Тетралгин»

A method for the accelerated determination of active pharmaceutical ingredients (APIs) in Tetralgin combined preparation has been developed based on the preliminary extraction separation of components, followed by obtaining their aqueous extracts and voltammetric titration with a solution of photogenerated iodine obtained as a result of irradiation of an auxiliary solution containing potassium iodide, a mixture of sensitizers (sodium eosinate : fluorescein : auramine, 1:1:1 molar ratio), and acetate buffer (pH 5.6). The extraction (chloroform) separation of drug components allows extracting from the model solution up to 97% caffeine (pH 11.0 – 12.0) and 98% phenobarbital (pH 4.5 – 5.5). The found contents of Tetralgin API components are within the range recommended by OFS.1.4.2.0009.15 so that the quality of drug tested meets GMP standards.