scholarly journals Determination of Arbutin in Herbal Medicinal Products

2021 ◽  
Vol 11 (2) ◽  
pp. 121-129
Author(s):  
N. P. Antonova ◽  
S. S. Prokhvatilova ◽  
E. P. Shefer ◽  
A. M. Kalinin ◽  
I. M. Morgunov ◽  
...  
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Subjective Assessment ◽  
Test Methods ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Visible Spectrophotometry ◽  
Spectrophotometric Methods ◽  
Titration Endpoint ◽  
Herbal Medicinal

Arbutin is the main active ingredient in many herbal medicinal products that have diuretic, antimicrobial, bactericidal, and antioxidant effects. Many of these products are mixtures of different herbal substances. Therefore, the approaches to quality control of HMPs can vary significantly. The aim of the study was to compare arbutin assay procedures used in quality control of arbutin-containing products. Materials and methods. Samples of the following HMPs were used in the study: monocomponent Bearberry Leaf and multicomponent Brusniver® (herbal mixture, powder). The test methods used were titrimetry, ultraviolet-visible spectrophotometry, and high-performance liquid chromatography (HPLC). Results. The authors compared five arbutin assay procedures described in the monographs and product files for arbutin-containing HMPs. Conclusions. It has been established that the analysed procedures cannot be used interchangeably as equivalent test methods; the limits for arbutin have to be established for each specific procedure. Iodometric titration is the most labour- and time-consuming method, and the determined titration endpoint is a subjective assessment. Spectrophotometric methods do not require the use of an arbutin reference standard, but they can give overestimated results as compared to the HPLC and titrimetry methods. HPLC methods are more selective, but they require the use of reference standards. The recommended test methods for HMP quality control are HPLC and visible spectrophotometry; the titrimetric method is recommended for replacement.

scholarly journals Validation of Standardized High-Performance Thin-Layer Chromatographic Methods for Quality Control and Stability Testing of Herbals

2003 ◽  
Vol 86 (5) ◽  
pp. 909-915 ◽  
Author(s):  
Kathrin Koll ◽  
Eike Reich ◽  
Anne Blatter ◽  
Markus Veit
Keyword(s):  
Quality Control ◽  
High Performance ◽  
Active Pharmaceutical Ingredient ◽  
Drug Preparation ◽  
Stability Testing ◽  
Herbal Drug ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Validation Parameters ◽  
Herbal Medicinal

Abstract In herbal medicinal products the entire herbal drug or an herbal drug preparation is regarded as the active pharmaceutical ingredient, regardless of whether constituents with defined therapeutic activity are known. In quality control and stability testing of herbal medicinal products, fingerprint chromatograms are used as powerful tools to evaluate and compare the composition of compounds in such products. To fulfill the International Conference on Harmonization and Good Manufacturing Practice-based regulatory requirements in pharmaceutical quality control, chromatographic fingerprint analysis needs to be validated. Based on a standardized methodology, this paper provides a comprehensive concept for evaluating validation parameters for planar chromatographic fingerprinting by considering the stationary phase, sample application, developing solvent, chromatogram development, plate labeling, derivatization, documentation, and chromatographic equipment. Validation parameters addressed include stability of the analyte, selectivity, robustness testing, and method reproducibility.

scholarly journals Comparative Analysis of Heavy Metal and Arsenic Content in Various Herbal Dosage Forms Marketed in Russia

2020 ◽  
Vol 10 (1) ◽  
pp. 41-50
Author(s):  
V. M. Shchukin ◽  
N. E. Kuz’mina ◽  
Yu. N. Shvetsova ◽  
A. I. Luttseva
Keyword(s):  
Sample Preparation ◽  
Inductively Coupled Plasma ◽  
Test Methods ◽  
Dosage Forms ◽  
Arsenic Content ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Current Test ◽  
Herbal Medicinal ◽  
Preparation Techniques

The inclusion of requirements for independent determination of arsenic, cadmium, mercury, and lead, and the current sample preparation techniques into the State Pharmacopoeia of the Russian Federation (Ph. Rus.) requires the revision of the existing limits for elemental toxicants in herbal substances and herbal medicinal products produced from them.The aim of the study was to analyse the data on elemental toxicant content obtained during quality control of herbal substances (herbs, medicinal herb mixtures, extracts, and tinctures) using current test methods and sample preparation techniques, and to compare the obtained results with the Russian and foreign scientific and specialist literature.Materials and methods: the internal data on the content of critical heavy metals and arsenic in different dosage forms of herbal medicinal products, which were obtained by inductively coupled plasma mass spectrometry after sample preparation by decomposition in closed vessels, were compared with literature data. Results: it was demonstrated that the content of lead, cadmium, and mercury in all the test samples did not exceed the Ph. Rus. limits and was consistent with the analysed literature. The arsenic content in some herbal medicinal products was higher than the established Ph. Rus. limits, but complied with the less stringent Ph. Eur. and USP requirements for herbal substances. The authors investigated the link between the content of elemental toxicants and the place of collection and the part of the plant being tested. It was shown that different types of medicinal plants had a tendency to accumulate particular elements. The authors determined the content of the elements to be controlled in extracts and tinctures. The differences in the Russian and foreign requirements for the content of elemental toxicants may be attributed to the method of obtaining experimental data that form the basis for the setting of limits.Conclusions: the results of the study confirm the validity of the existing limits for elemental toxicants in herbal medicinal products. The authors demonstrated the need to revise the existing limits for arsenic in herbal medicinal products.

scholarly journals Determination of Anthracene Derivatives in Herbal Medicines

2021 ◽  
Vol 11 (2) ◽  
pp. 104-114
Author(s):  
O. V. Evdokimova ◽  
A. V. Beketova ◽  
M. N. Lyakina
Keyword(s):  
Comparative Analysis ◽  
Herbal Medicines ◽  
Quality Standards ◽  
Test Methods ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Preparations ◽  
Anthracene Derivatives ◽  
Herbal Medicinal

The relevance of this study stems from the need for alignment of test methods used for identification and assay of anthracene derivatives in herbal preparations and herbal medicinal products. The aim of the study was to analyse Russian and international quality standards and to identify the most specific and sensitive test methods that could be used for herbal medicines containing anthracene derivatives. The comparative analysis of requirements in the Identification, Determination of major classes of bioactive compounds, and Assay parts of the Russian and foreign pharmacopoeial monographs for herbal preparations and herbal medicinal products containing anthracene derivatives, demonstrated that the main test method used for identification is thin layer chromatography, while assays most often rely on spectrophotometry. The so-called “consistent standardisation” principle is implemented in the Russian quality standards as regards alignment of methods used for anthracene derivative determination in herbal preparations (i.e. active pharmaceutical ingredients, APIs) and herbal medicinal products containing these APIs. The comparative analysis of requirements in the Russian and foreign quality standards for herbal medicines containing anthracene derivatives demonstrated the need for elaboration of two general chapters: Qualitative analysis of anthracene derivatives in herbal medicines and Quantitative analysis of anthracene derivatives in herbal medicines.

scholarly journals Quality control of herbal medicinal products and the South African perspective

2022 ◽  
pp. xv-xx
Author(s):  
Alvaro Viljoen ◽  
Weiyang Chen ◽  
Nduvho Mulaudzi ◽  
Guy Kamatou ◽  
Maxleene Sandasi
Keyword(s):  
Quality Control ◽  
South African ◽  
Medicinal Products ◽  
The South ◽  
Herbal Medicinal Products ◽  
African Perspective ◽  
Herbal Medicinal

scholarly journals Review: DNA Barcoding and Chromatography Fingerprints for the Authentication of Botanicals in Herbal Medicinal Products

2017 ◽  
Vol 2017 ◽  
pp. 1-28 ◽  
Author(s):  
Bashir Mohammed Abubakar ◽  
Faezah Mohd Salleh ◽  
Mohd Shahir Shamsir Omar ◽  
Alina Wagiran
Keyword(s):  
Quality Control ◽  
Dna Barcoding ◽  
Rapid Identification ◽  
Efficacy And Safety ◽  
Medicinal Products ◽  
Chromatographic Fingerprint ◽  
Closely Related Species ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal ◽  
Process Product

In the last two decades, there has been a tremendous increase in the global use of herbal medicinal products (HMPs) due to their claimed health benefits. This has led to increase in their demand and consequently, also, resulted in massive adulteration. This is due to the fact that most of the traditional methods cannot identify closely related species in a process product form. Therefore the urgent need for simple and rapid identification methods resulted in the discovery of a novel technique. DNA barcoding is a process that uses short DNA sequence from the standard genome for species identification. This technique is reliable and is not affected by external factors such as climates, age, or plant part. The difficulties in isolation of DNA of high quality in addition to other factors are among the challenges encountered using the DNA barcoding in the authentication of HMP. These limitations indicated that using DNA barcoding alone may ineffectively authenticate the HMP. Therefore, the combination of DNA barcoding with chromatographic fingerprint, a popular and generally accepted technique for the assessment and quality control of HMP, will offer an efficient solution to effectively evaluate the authenticity and quality consistency of HMP. Detailed and quality information about the main composition of the HMPs will help to ascertain their efficacy and safety as these are very important for quality control.

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