scholarly journals Scientific-methodological approach for standardization of herbal raw materials and herbal preparations using high-performance thin-layer chromatography procedure

2021 ◽  
pp. 76-89
Author(s):  
К. О. Хохлова

The high-performance thin-layer chromatography (HPTLC) is widely used for quality control of herbal raw materials (HRM). The purpose of this work were to define the problematic issues of quality control of herbal drugs in Ukraine and to develop a systematic scientific and methodological approach for the standardization of HRM and herbal drugs using the modern analytical technique of HPTLC: to optimize the existing and develop new methods of identification and determination of adulterations, and to develop alternative methods of quantitative determination, as well as studying of the stability. As a result of a critical evaluation of existing approaches for the standardization of HRM and herbal drugs of Ukraine’s flora, numerous problematic issues were identified, including the existence of a limited number of national monographs / national parts of monographs on the HRM of the Ukraine’s flora, which were not previously standardized by other pharmacopeias; non-consideration of Ukraine’s flora species (non-pharmacopoeial) in monographs on closely related species that introduced in the State Pharmacopoeia of Ukraine; lack of specificity of combinations of physical and chemical methods used for quality control; lack of specificity and reproducibility, the labor intensity of methods; necessity of usage of toxic solvents and precursors; use of different groups of markers and methods for the HRM and its finished product or HRM and its closely related species, etc. The proposed systematic scientific and methodological approach includes: a preliminary collection of information about the object of study, markers/groups of bioactive substances, approaches to its standardization; theoretical evaluation of existing techniques of quality control in monographs on HRM and experimental approbation using samples of domestic plants, determination of the need for optimization of existed methods by the parallel development of specific, reproducible and documented methods for identification, adulterations’ detection, quantification, and bio-detection (if necessary) by HPTLC method. The approach is illustrated with examples. The proposed approach can be used for comprehensive HPTLC analysis of domestic HRM and herbal drugs for research, prevention of adulteration, standardization of initial HRM and its finished product, pharmaceutical development, and stability studies.

2020 ◽  
pp. 215-222
Author(s):  
Ol'ga Valer'yevna Trineeva ◽  
Aleksey Ivanovich Slivkin

An analysis of the literature over the past 20 years has shown that when controlling the quality of drugs containing monosaccharides, as well as studying the composition of simple sugars in polysaccharide complexes of medicinal plants and not only, preference is given to physicochemical methods, as the most express, sensitive and informative. No means have been found in the scientific literature to identify and quantify simultaneously various monosaccharides by high performance thin layer chromatography (HPTLC). An economical and rapid method has been developed for the identification and quantitative determination of simple reducing sugars (by the example of glucose, rhamnose and xylose) by the HPTLC method. The optimal conditions for their chromatography in a thin layer of sorbent with a quantitative interpretation of HPTLC data on a personal computer were experimentally selected and theoretically substantiated. In a detailed study of the influence of the polarity of the system on the value of Rf, the intervals of values of the polarity of the eluent were chosen, in which these dependences become linear. Using the proposed dependencies, you can select different systems for the separation of monosaccharides in a thin layer of sorbent, so that the value of Rf fit into the optimal values. The proposed method was tested on medicinal plant raw materials of nettle dioica and sea buckthorn fruits of various conservation methods. Zones of simple sugars of characteristic color were found on the chromatograms of extracts from the studied raw materials, among which glucose, xylose and rhamnose were identified by the characteristic value of Rf values in comparison with reliable standard samples. The technique can be used in quality control of substances, single-component and complex preparations, plant objects, dietary supplements, premixes and products of the food industry.


2010 ◽  
Vol 93 (5) ◽  
pp. 1390-1398 ◽  
Author(s):  
Zhi Li ◽  
Irmgard Merfort ◽  
Eike Reich

Abstract Due to their complexity, multicomponent herbal drugs pose enormous analytical challenges for quality control (QC). Although they may have traditionally been used for hundreds of years, the information about their chemical composition is often still limited. Selecting suitable markers to monitor the identity and potency of the mixture is, therefore, difficult. There is also the possibility of natural variability for each plant. This paper illustrates a pragmatic and practical approach to QC of a multicomponent herbal drug by HPTLC. Cangzhu Xianglian San (CXS), composed of the herbal drugs Coptis rhizome, Aucklandia root, and Atractylodes rhizome (30 + 20 + 60, w/w/w), is used as an example. A characteristic fingerprint can be generated for CXS with tolueneethyl acetatemethanolisopropanolwater (60 + 30 + 20 + 15 + 3, v/v/v/v/v) mobile phase on HPTLC silica gel 60 conditioned with ammonia. While the corresponding monograph of the Chinese Veterinary Pharmacopoeia focuses only on the detection of berberine, one of the principal components of Coptis rhizome, the proposed method of identification determines the presence of all three components in the drug after derivatization with anisaldehyde reagent. The same method can also be used to quantitatively determine the content of berberine by scanning densitometry. This paper provides details about the validation of the qualitative and quantitative determinations.


Author(s):  
Rahma Yuni Safitri ◽  
Roslinda Rasyid ◽  
Regina Andayani ◽  
Harrizul Rivai

Clonidine is an α2-central agonist class of drugs widely used to treat cardiovascular diseases such as hypertension, heart attacks and help prevent strokes. The quality and safety of a drug preparation can be proven by testing the drug's quality assurance. In drug quality assurance, it is necessary to determine drug levels. Therefore, it is essential to look at the determination of clonidine levels in raw materials, mixtures, and pharmaceutical preparations. It is collecting data in this review article through trusted sites such as Google Scholar with the search keywords "clonidine hydrochloride," "clonidine analysis in pharmaceutical preparations" with a span of the last ten years (2010-2020). This review article aims to provide an overview of the various analytical techniques used to determine clonidine both in single substance form and in the pharmaceutical dosage form. Several analytical methods, such as UV-Visible spectrophotometry, potentiometry, high-performance liquid chromatography (HPLC), and high-performance thin-layer chromatography (HPTLC), have been reported to determine clonidine in the form of raw materials, mixtures, and pharmaceutical preparations. Overall, the determination of clonidine levels has been carried out by various analytical methods, including spectrophotometry, potentiometry, high-performance liquid chromatography (HPLC), and high-performance thin-layer chromatography (HPTLC). Analysis with the HPLC technique is widely used in research because it can detect samples with the lowest concentration. The HPLC-MS method has unique advantages and sensitivity in the analysis of clonidine in pharmaceutical preparations.


2020 ◽  
Vol 16 (6) ◽  
pp. 671-689
Author(s):  
Marcin Gackowski ◽  
Marcin Koba ◽  
Katarzyna Mądra-Gackowska ◽  
Piotr Kośliński ◽  
Stefan Kruszewski

At present, no one can imagine drug development, marketing and post-marketing without rigorous quality control at each stage. Only modern, selective, accurate and precise analytical methods for determination of active compounds, their degradation products and stability studies are able to assure the appropriate amount and purity of drugs administered every day to millions of patients all over the world. For routine control of drugs simple, economic, rapid and reliable methods are desirable. The major focus of current scrutiny is placed on high-performance thin layer chromatography and derivative spectrophotometry methods, which fulfill routine drug estimation’s expectations [1-4]. The present paper reveals state-of-the-art and possible applications of those methods in pharmaceutical analysis between 2010 and 2018. The review shows advantages of high-performance thin layer chromatography and derivative spectrophotometry, including accuracy and precision comparable to more expensive and time-consuming methods as well as additional fields of possible applications, which contribute to resolving many analytical problems in everyday laboratory practice.


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