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Comparative Evaluation of Assay Methods Used to Determine Anthracene Derivatives in Herbal Substances and Herbal Medicinal Products

https://doi.org/10.30895/1991-2919-2018-8-4-252-261

Abstract

 The use of assay methods with different test conditions for determination of anthracene derivatives in herbal substances and herbal medicinal products requires adjustment of the established limits for total anthracene derivatives content based on the test method used.

The aim of the study was to compare different pharmacopoeial methods of quantitative determination of anthracene derivatives, and established limits for the active substance content, and to analyse the possibility of adjusting the limits based on the test method used.

Materials and methods: the total content of anthracene derivatives was measured in the samples of frangula bark (fragmented bark and powder) and senna leaves (fragmented leaves and powder) using the test methods described in the State Pharmacopoeia of the Russian Federation (XI and XIII editions), and the European Pharmacopoeia.

Results: the analysis of Russian and foreign pharmacopoeial requirements for determination of anthracene derivatives in laxative herbal medicinal products demonstrated differences in extraction solvents, extraction conditions, and calculation methods used. The experiments showed that the optimal extraction solvent was 70 % alcohol solutions, and that an indirect cobaltic chloride reference standard should be replaced by specific absorbance of glucofrangulin A and sennoside B. It was shown that the limits for total anthracene derivatives content should be chosen based on the extraction conditions used.

Conclusions: comparative theoretical research and experimental studies helped to determine optimal assay conditions and respective limits for total anthracene derivatives content to be used in quality control of herbal substances and herbal medicinal products.   

About the Authors

N. P. Antonova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Biol.), Head of the Laboratory of Herbal and Homeopathic Products of the Testing Centre for Evaluation of Medicinal Products’ Quality

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



I. M. Morgunov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

2nd Professional Category Expert of the Laboratory of Herbal and Homeopathic Products of the Testing Centre for Evaluation of Medicinal Products’ Quality

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



S. S. Prokhvatilova
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Pharm.), Chief Expert of the Laboratory of Herbal and Homeopathic Products of the Testing Centre for Evaluation of Medicinal Products’ Quality

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



E. P. Shefer
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Cand. Sci. (Pharm.), Chief Expert of the Laboratory of Herbal and Homeopathic Products of the Testing Centre for Evaluation of Medicinal Products’ Quality

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



A. M. Kalinin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation

Leading Expert of the Laboratory of Herbal and Homeopathic Products of the Testing Centre for Evaluation of Medicinal
Products’ Quality

8/2 Petrovsky Blvd, Moscow 127051, Russian Federation



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Review

For citations:


Antonova N.P., Morgunov I.M., Prokhvatilova S.S., Shefer E.P., Kalinin A.M. Comparative Evaluation of Assay Methods Used to Determine Anthracene Derivatives in Herbal Substances and Herbal Medicinal Products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2018;8(4):252-261. (In Russ.) https://doi.org/10.30895/1991-2919-2018-8-4-252-261

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