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

Authors

  • V. A. Khanin Pharmaceutical company “Zdorovye”, Ltd., Ukraine
  • O. O. Moiseev National University of Pharmacy, Ukraine
  • A. Ye. Babkina Ivan Kozhedub Kharkiv University of Air Force, Ukraine
  • O. M. Kotenko National University of Pharmacy, Ukraine
  • A. G. Kotov SE “Ukrainian Scientific Pharmacopeial Centre of Drug Quality”, Ukraine

DOI:

https://doi.org/10.24959/nphj.16.2126

Keywords:

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

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.

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.

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Published

2016-06-13

Issue

Section

Synthesis and Analysis of Biologically Active Substances