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Information × Registration Number 0216U006263, 0115U001061 , R & D reports Title Development, methodological and metrological study ways to control the quality of dosage forms flupirtine maleate and calcium rozuvastatin popup.stage_title Head Antonovich V.P., Registration Date 24-02-2016 Organization A.V.Bogatsky Physico-Chemical Institute of the National Academy of Sciences of Ukraine popup.description2 To quantify the primary pharmaceutical ingredient (flupirtine maleate) in capsules and tablets simple and rapid procedures of spectrophotometric and luminescent determination of it in 0.1 M hydrochloric acid solution medium are developed and validated. It was proposed the fluorescent method for the quantitative determination of flupirtine maleate in swabs from surfaces of pharmaceutical equipment on which appropriate dosage forms are produced. In various media investigated the dissolution profiles of the reference (EFIRET®, capsules 100 mg; MEDA Pharma SpA, Italy) and playback (flupirtine maleate capsules of 100 mg, ODO "INTERHIM") drugs and it was concluded that they are similar when dissolved in 0, 1 M HCl (similarity factor f2 is 56,90), but not in solutions with pH 4,5 (f2 = 27,27) and pH 6.8 (f2 = 20.86).Using the HPLC method a new test method "Related substances" was developed and validated. The possibility of selective separation of the peaks for identifing impurity components was shown. It is found that the proposed method is specific, accurate and correctly characterized correctness when determining accompanying impurities and can be used in the quality control of various dosage forms of flupirtine maleate Product Description popup.authors І.І. Леоненко А.А.Федосенко А.В. Єгорова В.П.Антонович Н.П. Єфрюшина О.І. Теслюк Ю.В.Скрипинець popup.nrat_date 2020-04-02 Close