Регуляторные исследования и экспертиза лекарственных средств (Dec 2023)
Modern methods for identification and quantification of cardiac glycosides
Abstract
Scientific relevance. Cardiac glycosides have been used in medicine for over two centuries. Current studies suggest that biologically active substances from this group can be used to treat not only heart conditions but also viral infections, cancers, and other diseases. Therefore, quality control methods for cardiac glycosides are becoming increasingly relevant.Aim. Based on a review of Russian and international quality standards, as well as up-to-date scientific data, this study aimed to identify promising methods for the identification and quantification of cardiac glycosides in herbal drugs and herbal medicinal products, as well as to evaluate the possibility of substituting physicochemical methods for biological methods.Discussion. The methods that are currently used to standardise cardiac glycosides are either not selective or require laboratory animals (biological test systems). According to a study of pharmacopoeial methods for the identification of cardiac glycosides in herbal drugs and herbal medicinal products, chemical identification tests and thin-layer chromatography continue to be relevant. Quantitative testing of herbal drugs and extracts uses biological and non-selective (spectrophotometry) methods, whereas chromatography is described only in general and individual monographs for herbal drug preparations containing individual cardiac glycosides and medicinal products containing these preparations. Upon analysing quality standards and scientific publications, the authors identified potentially promising methods for the quantification of cardiac glycosides in herbal drugs, herbal drug preparations, and herbal medicinal products, namely chromatographic methods.Conclusions. Reverse-phase high-performance liquid cjromatography (HPLC) with spectrophotometric detection is the most suitable method for pharmacopoeial analysis. The development of an HPLC-based analytical procedure to determine the cardiac glycoside content will provide an opportunity to advance from biological or non-selective methods to more ethical and selective up-to-date techniques.
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