vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2021-11-174-184vedomostiregmed-369Research ArticleОБЗОРЫREVIEWSАнализ витамина А в поливитаминных препаратахAnalysis of Vitamin A in Multivitamin Productshttps://orcid.org/0000-0002-6094-8990АлексееваА. С.AlekseevaA. S.

Алексеева Анастасия Сергеевна, кандидат фармацевтических наук,

Петровский б-р, д. 8, стр. 2, Москва, 127051

Anastasia S. Alekseeva, Cand. Sci. (Pharm.),

8/2 Petrovsky Blvd, Moscow 127051

AlekseevaAS@expmed.ruhttps://orcid.org/0000-0003-3720-9687ШемерянкинаТ. Б.ShemeryankinaT. B.

Шемерянкина Татьяна Борисовна, кандидат фармацевтических наук,

Петровский б-р, д. 8, стр. 2, Москва, 127051

Tatiana B. Shemeryankina, Cand. Sci. (Pharm.),

8/2 Petrovsky Blvd, Moscow 127051

Shemeryankina@expmed.ruhttps://orcid.org/0000-0002-8220-1054ЛякинаМ. Н.LyakinaM. N.

Лякина Марина Николаевна, доктор фармацевтических наук,

Петровский б-р, д. 8, стр. 2, Москва, 127051

Marina N. Lyakina, Dr. Sci (Pharm.),

8/2 Petrovsky Blvd, Moscow 127051

Ljakina@expmed.ruhttps://orcid.org/0000-0002-0305-5934СмирноваМ. С.SmirnovaM. S.

Смирнова Мария Сергеевна,

Петровский б-р, д. 8, стр. 2, Москва, 127051

Maria S. Smirnova,

8/2 Petrovsky Blvd, Moscow 127051

smirnovams@expmed.ruhttps://orcid.org/0000-0002-4499-2190ФедороваЕ. П.FedorovaE. P.

Федорова Елена Павловна, кандидат фармацевтических наук,

Петровский б-р, д. 8, стр. 2, Москва, 127051

Elena P. Fedorova, Cand. Sci. (Pharm.),

8/2 Petrovsky Blvd, Moscow 127051

fedorovaep@expmed.ruhttps://orcid.org/0000-0002-8160-7829КахрамановаС. Д.KakhramanovaS. D.

Кахраманова Сабина Джейхуновна,

Петровский б-р, д. 8, стр. 2, Москва, 127051

Sabina D. Kakhramanova,

8/2 Petrovsky Blvd, Moscow 127051

kahramanovasd@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202109082021113174184Copyright © Алексеева А.С., Шемерянкина Т.Б., Лякина М.Н., Смирнова М.С., Федорова Е.П., Кахраманова С.Д., 20212021Алексеева А.С., Шемерянкина Т.Б., Лякина М.Н., Смирнова М.С., Федорова Е.П., Кахраманова С.Д.Alekseeva A.S., Shemeryankina T.B., Lyakina M.N., Smirnova M.S., Fedorova E.P., Kakhramanova S.D.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/369

Витамин А в поливитаминных лекарственных препаратах представлен преимущественно в виде эфиров ретинола: ретинола ацетата, ретинола пальмитата, а также бетакаротена – предшественника (димера) ретинола, содержащегося в растениях и способного превращаться в ретинол в клетках печени. В составе лекарственных средств ретинол анализируется преимущественно методом высокоэффективной жидкостной хроматографии (ВЭЖХ) с предварительной очисткой и выделением витамина методом жидкостной экстракции. Однако в научной литературе встречаются и другие способы подготовки пробы и анализа этих соединений. Важным аспектом является также разделение витамина А с другими жирорастворимыми витаминами, которые наряду с витамином А входят в состав поливитаминных препаратов. Цель работы - анализ и обобщение данных литературы о современных методах определения витамина А и его производных в лекарственных препаратах. Проведен анализ номенклатуры препаратов, содержащих витамин А и зарегистрированных в Российской Федерации, а также методов анализа, используемых согласно нормативной документации производителей этих препаратов. Показано, что наиболее распространенным методом анализа эфиров ретинола является ВЭЖХ в изократическом режиме элюирования на октадецилсилильных сорбентах в обращенно-фазовом режиме, реже на аминопропилсилильных сорбентах в нормально-фазовом режиме элюирования. Бетакаротен в лекарственных средствах определяется преимущественно методом спектрофотометрии.

Vitamin A is present in multivitamin products mainly in the form of retinol esters: retinyl acetate, retinyl palmitate, and beta carotene—retinol precursor (dimer) found in plants, which is capable of converting into retinol in liver cells. Retinol is determined in medicinal products primarily by high performance liquid chromatography (HPLC), with preliminary purification and vitamin isolation by liquid-liquid extraction. However, scientific literature also describes other methods of sample preparation and analysis of such compounds. An important issue is differentiation of vitamin A from other fat-soluble vitamins often included as components in multivitamin products. The aim of the study was to analyse and summarise data on current methods used for determination of vitamin A and its derivatives in medicinal products. The authors analysed the range of vitamin A products authorised in the Russian Federation, and the test methods described in their product specification files. The study demonstrated that the test method most often used for determination of retinol esters was HPLC with isocratic elution mode using octadecylsilyl packing in the reverse-phase mode, and, less frequently, aminopropylsilyl packing in the normal phase mode. Determination of beta carotene in medicinal products is most often performed using spectrophotometry. 

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The authors declare that there are no conflicts of interest present.