Аннотация:
Species, known as mixture herbal products, are compositions of several types of crushed, sometimes whole, medicinal plant materials with additives; they are a widely used dosage form in the Russian Federation. A large range of species are produced at the pharmaceutical companies. In pharmacopoeial analysis, the most popular and widely used method for the determination of flavonoids, suitable for the standardization of species, is the method of differential spectrophotometry, based on the complexation of flavonoids with aluminum chloride. In accordance with modern requirements for the drugs production, the validation of analytical methods is a prerequisite for the creation of pharmacopoeial monographs projects regulating the quality of pharmaceutical substances of plant origin. Therefore, it is necessary to validate analytical methods for their intended use in evaluating the drug quality. This article discusses/presents the main stages of development and validation (by parameters: accur
Ключевые слова:
Medicinal plant materials; mixture herbal products; pharmacopoeial analysis; species; spectrophotometric analysis method; total flavonoid content; validation
aluminum chloride; fitourol; flavonoid; herbaceous agent; luteolin 7 glycoside; unclassified drug; Article; complex formation; controlled study; drug determination; drug isolation; drug quality; herbal medicine; medicinal plant; particle size; priority journal; process development; quality control; quantitative analysis; spectrophotometry; standardization; ultraviolet visible spectrophotometry; validation process
Smy'slova O. A. Ol`ga Aleksandrovna 1977-
Bokov D. O. Dmitrij Olegovich 1991-
Potanina O.
Litvinova T. M. Tat`yana Mikhaylovna 1962-
Samy'lina I. A. Irina Aleksandrovna 1943-
Смыслова О. А. Ольга Александровна 1977-
Боков Д. О. Дмитрий Олегович 1991-
Потанина О.
Литвинова Т. М. Татьяна Михайловна 1962-
Самылина И. А. Ирина Александровна 1943-
Development and validation of spectrophotometric procedure for quantitative determination of flavonoid content used to control the quality of mixture herbal product
Development and validation of spectrophotometric procedure for quantitative determination of flavonoid content used to control the quality of...
Текст визуальный непосредственный
Journal of Advanced Pharmaceutical Technology and Research
Vol.10, Issue4 P. 155-162
2019
Статья
Medicinal plant materials mixture herbal products pharmacopoeial analysis species spectrophotometric analysis method total flavonoid content validation
aluminum chloride fitourol flavonoid herbaceous agent luteolin 7 glycoside unclassified drug Article complex formation controlled study drug determination drug isolation drug quality herbal medicine medicinal plant particle size priority journal process development quality control quantitative analysis spectrophotometry standardization ultraviolet visible spectrophotometry validation process
Species, known as mixture herbal products, are compositions of several types of crushed, sometimes whole, medicinal plant materials with additives; they are a widely used dosage form in the Russian Federation. A large range of species are produced at the pharmaceutical companies. In pharmacopoeial analysis, the most popular and widely used method for the determination of flavonoids, suitable for the standardization of species, is the method of differential spectrophotometry, based on the complexation of flavonoids with aluminum chloride. In accordance with modern requirements for the drugs production, the validation of analytical methods is a prerequisite for the creation of pharmacopoeial monographs projects regulating the quality of pharmaceutical substances of plant origin. Therefore, it is necessary to validate analytical methods for their intended use in evaluating the drug quality. This article discusses/presents the main stages of development and validation (by parameters: accur