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

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 aimof 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.