Development of the new approach to quality control of extracts of the plant raw material on the example of Convallaria majalis

V. A. Khanin, O. O. Moiseev, A. Ye. Babkina, O. M. Kotenko, A. G. Kotov

Abstract


Currently, there is a significant amount of drugs created on the basis of the medicinal raw material of the natural origin at the pharmaceutical market of Ukraine. An important source of the medicinal plant raw material for manufacture of cardiotonic drugs is lily-of-the-valley (Convallaria Majalis). The extract of lily-of-the-valley contains a significant amount of cardiac glycosides; some of them are well studied and is widely used in pharmacy. To control the quality of the plant raw material specified the HPLC-MS method for identification and quantitative determination of the basic components of the lily-of-the-valley extract has been developed and validated. The new approach to identification and quantitative determination of the components of systems of the natural origin by chromatographic methods has been proposed; it allows tightening the requirements for quality of the medicinal raw material and fixing the quantitative composition of the raw material within a rather narrow range. Fixing the composition of the raw material will provide the achievement of the pharmacological effect envisaged by the developers of the drug. The application of the approach developed to the analysis of the medicinal raw material also helps to simplify and reduce the cost of pharmaceutical analysis.

Keywords


HPLC-MS; identification; quantitative determination; multicomponent systems; medicinal plant raw material

Full Text:

PDF

References


Державна фармакопея України: в 3 т. / Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів». – 2-е вид. – Х.: Державне підприємство «Український науковий фармакопейний центр якості лікарських засобів», 2015. – Т. 1. – 1128 с.

Довідник лікарських засобів, зареєстрованих в Україні [Електронний ресурс]. – Режим доступу: https://medhub.info/31246dcb

Литвиненко В.И., Попова Т.П., Дихтярев С.И. та ін. // Фітотерапія. Часопис. – 2012. – №2. – С. 59-62.

Шостак Т.А., Калинюк Т.Г., Гудзь Н.І. // Фітотерапія. Часопис. – 2014. – №4. – С. 77-82.

Chushenko V.N., Vinnik E.V., Komissarenko N.F. et al. // Chem. Nat. Compd. – 1992. – Vol. 28. – P. 242-243.

European Pharmacopoeia – 8-th ed. – Strasbourg: European Directorate for the Quality of Medicines, Council of Europe, 2013ю – 3655 p.

Kopp B., Kubelka W. // Planta Med. – 1982. – Vol. 45. – P. 195-202.

Moiseev O.O., Dorovskoi O.V., Khanin V.A. et al. // Вісник фармації. – 2013. – №4 – С. 19-22.

The United State Pharmacopeia: 37 – NF32, Rockville: The United State Pharmacopeia, Inc., 2014, 3503 p.


GOST Style Citations






DOI: https://doi.org/10.24959/88778

Abbreviated key title: Vìsn. farm.

ISSN 2415-8844 (Online), ISSN 1562-7241 (Print)