scholarly journals Application of HPLC for Evaluation and Standardisation of Hawthorn Flower Herbal Substance

2019 ◽  
Vol 9 (3) ◽  
pp. 177-183
Author(s):  
N. P. Antonova ◽  
E. P. Shefer ◽  
N. E. Semenova ◽  
A. M. Kalinin ◽  
S. S. Prokhvatilova ◽  
...  
Keyword(s):  
Quantitative Determination ◽  
Russian Federation ◽  
High Performance ◽  
Primary Standard ◽  
Test Procedure ◽  
Total Content ◽  
The State ◽  
Assay Method ◽  
The Russian Federation

The process of harmonisation of Russian and foreign approaches and requirements in the field of medicines quality assurance calls for revision of quality control procedures included in various regulations and guidelines. The monograph FS.2.5.0062.18 “Hawthorn flowers” of the State Pharmacopoeia of the Russian Federation XIV edition includes a test procedure for determination of flavonoids by a chromatospectrophotometric method. This procedure does not take into account current scientific capabilities and has a number of shortcomings, therefore it was necessary to revise the existing test procedure and develop a new approach to the standardisation of the hawthorn flower herbal substance.The objective of the study was to develop an assay method for standardisation and evaluation of hawthorn flower using high performance liquid chromatography (HPLC).Materials and methods: the study was performed using samples of hawthorn flowers by Russian manufacturers. Quercetin (USP RS) and Hyperoside (HWI, primary standard) were used as the reference standards. The HPLC analysis was performed using an Infinity II 1260 DAD LC system (Agilent), and the UV spectra were recorded on a Cary 100 Varian spectrophotometer. A TLC Visualizer (CAMAG) was used to obtain digital images of thin layer chromatography plates.Results: the authors developed an HPLC test procedure for quantitative determination of total flavonoids, expressed as hyperoside, in hawthorn flowers. The developed procedure gives reliable and reproducible results and is characterised by high sensitivity and selectivity. The results of quantitative determination of the total flavonoid content in hawthorn flowers were used to propose the standard for the total content of flavonoids, expressed as hyperoside, of “not less than 0.5%”.Conclusions: the developed assay method for determination of active pharmaceutical ingredients in hawthorn flower products by HPLC can be recommended for inclusion into the Assay part of the “Hawthorn Flowers” monograph of the State Pharmacopoeia of the Russian Federation.

scholarly journals Current Approaches to Valerian Tincture Standardisation in Terms of Assay

2019 ◽  
Vol 9 (4) ◽  
pp. 265-271
Author(s):  
N. P. Antonova ◽  
E. P. Shefer ◽  
A. M. Kalinin ◽  
N. E. Semenova ◽  
S. S. Prokhvatilova ◽  
...  
Keyword(s):  
Quantitative Analysis ◽  
Quantitative Determination ◽  
High Performance ◽  
Test Procedure ◽  
Total Content ◽  
Reference Standard ◽  
Active Ingredients ◽  
Test Procedures ◽  
Valerenic Acid

The quality control of the «Valerian rhizome and roots» herbal substance is carried out using high performance liquid chromatography (HPLC) according to the State Pharmacopoeia of the Russian Federation, XIV edition. The quantitative analysis of the active ingredients in valerian tincture is performed using a non-specific and non-selective spectrophotometric method. Therefore, it is important to introduce in Russia a more modern test procedure for quantitative determination of active ingredients in valerian tincture.The aim of the study was to develop a selective and sensitive HPLC procedure for quantitative determination of the total content of sesquiterpenic acids, expressed as valerenic acid, for the purpose of valerian tincture standardisation.Materials and methods: valerian tincture samples produced by seven Russian manufacturers were used as test samples, and valerenic acid was used as the reference standard. The quantitative analysis of the active ingredients was performed by two methods: spectrophotometry at 512 nm following the reaction of valerenic acid ethylester with hydroxyalamine and ferric chloride, and by HPLC using a Nucleosil C18 column, 125×4.6 mm, 5 µm particle size, in gradient elution mode, with detection at 220 nm.Results: the spectrophotometric technique was shown to be insufficiently specific. The authors of the study validated the chromatographic test procedure, established system suitability criteria, and compared the results obtained by the two test procedures. They also determined a tentative standard of the total content of sesquiterpenic acids, expressed as valerenic acid, obtained by HPLC.Conclusions: the HPLC assay developed for quantitative determination of active ingredients in valerian tincture is more specific as compared to the spectrophotometric technique, as the sum of the peaks of valerenic and acetoxyvalerenic acids and the results for the reference standard are taken into account during calculations. The new test procedure is in line with the cross-cutting standardisation principle and can be recommended for inclusion into the draft monograph «Valerian tincture».

scholarly journals EXTRACTION SPECIMENS BASED ON THE BUCKTHORN BARK AND METHODOLOGICAL APPROACHES TO IDENTIFY ANTHRACENE DERIVATIVES INCLUDED

2018 ◽  
pp. 73-81
Author(s):  
Natal'ya Anatol'yevna Borovikova
Keyword(s):  
Quantitative Determination ◽  
Russian Federation ◽  
Raw Materials ◽  
Sodium Hydroxide Solution ◽  
The State ◽  
Raw Material ◽  
Extraction Temperature ◽  
Anthracene Derivatives ◽  
The Russian Federation

The article provides an overview of drugs based on buckthorn bark included in the State register of medicines of the Russian Federation and patented in recent years. The methods of quantitative determination of anthracenes-derived raw materials of buckthorn according to the state Pharmacopoeia of the Russian Federation XI and XIII editions and the European Pharmacopoeia are analyzed and presented in the comparative aspect. The main representatives of the anthracene-derived buckthorn are shown for a number of sources, taking into account modern phytochemical studies. The algorithm of development of a technique of spectrophotometric quantitative determination of anthracenes derivatives in buckthorn bark and extraction preparations from it is gradually presented. Studied and selected the optimal conditions of extraction: raw material grinding – 1 mm, extractant – 10% sodium hydroxide solution, the ratio of raw materials and extractant – 0.1 : 100, the extraction temperature in a water bath 100 °C, the duration of extraction – 30 minutes. The analytical maximum of 510 nm was established, a certified sample of frangul-emodin was used as a standard substance, and an experimental calculation of the specific absorption rate of frangul-emodin interaction products with an alkaline-ammonia mixture was presented. In the research we describe an optimized pharmacopoeial methodology, metrological characterizations and results of quantitative determination of the anthracene derivatives in aqueous and alcohol extracts based on the buckthorn bark. The content of the amount of anthracenes in the samples of raw materials of five domestic producers. The content varies from 4.35 to 4.85%.

scholarly journals DEvELopMENT of TEOHNiQuEs FoR THE DETERMiNATioN oF MoisTuRE (Loss oN DRYING) oF MEDiOiNAL PLANT RAW MATERiALS oF MoRPHoLoGiOAL group “FRUiT” by infrared thermogravimetric method

2019 ◽  
Vol 19 (1-2) ◽  
pp. 13-18
Author(s):  
D. A Zhdanov ◽  
V. B Braslavsky
Keyword(s):  
Medicinal Plant ◽  
Russian Federation ◽  
Raw Materials ◽  
The State ◽  
Moisture Loss ◽  
Anethum Graveolens ◽  
Thermogravimetric Method ◽  
Plant Raw Materials ◽  
The Russian Federation

The article is devoted to the development of new and perspective for the State Pharmacopoeia of the Russian Federation (SP RF) techniques for determining of the moisture (loss on drying) of medicinal plant raw materials of the morphological group “Fruit” and medicinal plant preparations by the use of infrared thermogravimetric (IRTGM) method. The techniques for determination of moisture (loss on drying) IRTGM-method as exemplified by the fruit of the following medicinal plants: Silybum marianum (L.) Gaertn., Rosa cinnamomea L. and Anethum graveolens L. were developed. The comparable results for determining of the moisture (loss on drying) of the medicinal plant raw materials of investigated plants were obtained by means of two methods: IRTGM and pharmacopoeial method, which allow us to recommend the developed techniques for inclusion into the relevant monographs of the State Pharmacopoeia of the Russian Federation.

Application of the high-resolution HPLC–MS/MS method for identification and quantitative determination of impurities in the substance of the drug «Lomustine»

2021 ◽  
pp. 68-70 ◽  
Author(s):  
I.O. Reshetnikova ◽  
S.V. Metlitskikh ◽  
N.D. Stekleneva ◽  
A.N. Volov
Keyword(s):  
Quality Control ◽  
High Resolution ◽  
Quantitative Determination ◽  
Russian Federation ◽  
Malignant Tumors ◽  
Medical Industry ◽  
Medicinal Substances ◽  
The Russian Federation ◽  
Determination Of Impurities

Due to the state program of the Russian Federation "Development of the pharmaceutical and medical industry" (Pharma-2020), extended until 2024, the interest in the possibility of organizing the production and quality control of imported medicinal substances directly on the territory of the Russian Federation has significantly increased. In this case, the drugs included in the lists of "Indispensible and essential drugs" and "Provision of necessary drugs" [1] are of particular importance. One of the drugs often used in the chemotherapy of malignant tumors is the drug "Lomustine", which includes 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea as an active ingredient [1-3].

scholarly journals The Attitude of High-Class Athletes to Doping in Sports and Measures to Counter It

2021 ◽  
Vol 20 (2) ◽  
pp. 134-143
Author(s):  
Olga S. Kulyamina ◽  
◽  
Maria I. Tarasova ◽  
Eugenia M. Bronnikova ◽  
◽  
...  
Keyword(s):  
Russian Federation ◽  
Integrated Approach ◽  
The State ◽  
Doping Analysis ◽  
High Class ◽  
Doping In Sports ◽  
Scope Of Application ◽  
The Subject ◽  
The Russian Federation

The subject of the study is the attitude of high-class athletes to doping in sports and measures to counter it. The methodology of the work consists in the application of a set of techniques and methods that made it possible to use an integrated approach to the research. The results of the study are systematized data on attitudes towards and awareness of doping, analysis of the prevalence of information about doping in sports, identification of causes, consequences and determination of methods to combat it based on the data of surveys of high-class athletes for the period from 2019 to 2021. The scope of application of the research results affects the sports of the Russian Federation. The novelty of the study lies in the assessment of the state and potential of doping in sports in Russia over the course of 3 years. According to the results of the study, the main trends of athletes opinions about doping were identified, revealing the possibilities of improving the fight against doping in sports, which will ultimately contribute to improving the anti-doping culture in the country.

Validation of assay method of cardiazole by highly efficient liquid chromatography

2020 ◽  
Vol 26 (4) ◽  
pp. 80-90
Author(s):  
I.V. Drapak ◽  
Keyword(s):  
High Performance Liquid Chromatography ◽  
Liquid Chromatography ◽  
Quantitative Determination ◽  
Analytical Method ◽  
High Performance ◽  
Antioxidant Properties ◽  
Stability Study ◽  
Assay Method ◽  
Validation Parameters

Aim. Validation of the method of quantitative determination of Cardiazole substance by high-performing liquid chromatography technique. Materials and Methods. The object of the study was the [3-allyl-4-(41-methoxyphenyl)-3H-thiazol-2-ylidene]-(32-trifluoromethylphenyl)-amine hydrobromide (Cardiazole) which possesses cardioprotective, anti-inflammatory, analgesic, hypolipidemic, antihypoxic, and antioxidant properties. The compound is patented and involved in the development plan of "Farmak" pharmaceutical company for further preclinical studies workflow. High-performance liquid chromatography was used for the quantitative determination of the Cardiazole substance. Validation of the proposed methodology was performed in accordance with the requirements of the State and European Pharmacopoeias requirements. The obtained data were analyzed using Analyst 1.5.2., as well as Statistica 10.0 and Microsoft Excel software. Results and Discussions. The high-performance liquid chromatography analytical method for the quantitative determination of Cardiazole substance was validated based on the main parameters according to the pharmacopeia requirements. The specificity of the technique was confirmed by comparing the chromatograms of the comparison solution, the test solution, and the blank solution. The linearity parameters are set over the entire range of the analyzed Cardiazole concentrations. The parameters of the correctness of the 9 prepared test solutions within the range of the analytical method application have met the following criteria: requirements for statistical and practical insignificance. The study of the parameters of intra-laboratory precision of 3 tests of the same sample was carried out by two analysts on different days during one week using different measuring ware. Thus, compliance with the criteria was confirmed. The obtained results of the experimental determining of the validation characteristics confirmed the correctness of the technique while reproduced in other laboratories. The results of the stability study showed: for optimal chromatography conditions it is necessary to use a freshly prepared solution of Cardiazole (within 24 hours). Conclusions. The evaluation of the validation parameters of the method of quantitative determination of Cardiazole by high-performance liquid chromatography was carried out. It was shown that the presented method of analysis of Cardiazole meets the requirements for specificity, linearity, accuracy, precision, and stability. The validated analytical method for the quantitative determination of Cardiazole by high-performance liquid chromatography can be used for standardization of the Cardiazole substance, as well as for studying the pharmacokinetics and pharmacodynamics, bioequivalence, and pharmaceutical development of dosage forms. Keywords: validation parameters, Cardiazole, high-performance liquid chromatography

scholarly journals Determination of the marker compounds for standardization medicinal herbal species «Pectorales tea №1» and «Proctofitol»

2020 ◽  
Vol 2 (2) ◽  
pp. 38-47
Author(s):  
Inna I. Terninko ◽  
Evgeny V. Vishnyakov ◽  
Margarita A. Romanova ◽  
Yulia E. Generalova
Keyword(s):  
Attenuation Coefficient ◽  
Russian Federation ◽  
Rosmarinic Acid ◽  
Glycyrrhizic Acid ◽  
Mass Attenuation Coefficient ◽  
The State ◽  
Hydroxycinnamic Acids ◽  
The Russian Federation ◽  
Mass Attenuation

The State Pharmacopoeia of the Russian Federation 14th ed. suggests to standardize herbal teas using the procedures presented in the pharmacopoeia monographs but this approach is not always relevant due to complexity of this dosage form composition. The purpose of investigation is to estimate quality of herbal teas utilizing monographs recommended by the State Pharmacopoeia of the Russian Federation 14th ed. for the individual components of teas and suggest feasible alternative approaches to standardization of multicomponent herbal drugs. The objects of investigation Pectorales species № 1 and Proctofitol. Detection of substances was carried out using chromatographic (TLC and HPLC) and spectrophotometric methods recommended by the State Pharmacopoeia of the Russian Federation 14th ed. for individual components measured in term of marker biological active substances or substances found in the course of quality analysis. It has been found out that the content of flavonoids measured in terms of giperosid surpasses over the equivalent figure in terms of luteolin in the extractions from Pectorales species № 1. The content of hydroxycinnamic acids in the same tea measured in terms of rosmarinic acid surpasses over the equivalent figure in terms of chlorogenic acid. Analysis of anthracene derivates in the Proctofitol has shown that the adsorption maximum of phenolate solution of anthracene derivates (523 nm) coincides with maximum by which was calculated the mass attenuation coefficient of sennoside B (523 nm) (for chrysophanic acid = 515 nm) and the maximum of adsorption of extraction from the tea with using alcohol solution of magnesium acetate (515 nm) coincides with maximum by which was calculated the mass attenuation coefficient of glucofrangulin A. Preliminary cleaning Proctofitol off anthracene derivates allowed to estimate the content of glycyrrhizic acid more completely. The giperosid was suggested as a marker substance for determination of flavonoids, rosmarinic acid was suggested as a standard for hydroxycinnamic acids in Pectorales species № 1. The sennoside B was suggested as a marker for estimating of content of anthracene derivates in the Proctofitol and the necessity of cleaning this tea off anthracene derivates when defining glycyrrhizic acid was proven.

scholarly journals Validation of assay method of nifedipine in tablets by liquid chromatography

2017 ◽  
Author(s):  
L. S. Lohoyda
Keyword(s):  
Liquid Chromatography ◽  
Quantitative Determination ◽  
High Performance ◽  
Hplc Method ◽  
Assay Method ◽  
Liquid Chromatograph ◽  
System A ◽  
Validation Of Methods ◽  
Validation Parameters

The aim of this study was the validation of methods of quantitative determination of nifedipine in  tablets by liquid chromatography. The chromatographic analysis was performed on nifedipine liquid chromatograph Agilent 1290 Infinity II LC System. A validation of methods of quantitative determination of nifedipine by high performance liquid chromatography tablets was performed. It was established that the method proves the requirements of the State Pharmacopoeia of Ukraine for the main validation parameters: specificity, accuracy, linearity, robasnist. The results obtained in this study clearly indicate that the developed HPLC method is fast, economical, simple, accurate and suitable for determination of nifedipine in medicines.

scholarly journals Prospects for Chinese-Russian cooperation in the dairy sector

R-Economy ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. 52-60
Author(s):  
Qiujie Chen ◽  
Keyword(s):  
Russian Federation ◽  
Dairy Products ◽  
Global Economy ◽  
High Performance ◽  
Strong Support ◽  
Field Research ◽  
State Level ◽  
The State ◽  
Common Interest ◽  
The Russian Federation

Relevance. The COVID-19 pandemic is a new challenge facing humanity, which has already caused serious damage to the global economy. In particular, international cooperation has faced somewhat unprecedented challenges. In the post-pandemic era, it is extremely important to study the state of the dairy sector in China in order to find a way to develop cooperation between the People’s Republic of China and the Russian Federation in this field. Research objective. To analyse the state of China’s dairy sector in the post-pandemic period, taking into account the trend of recovery, as well as to identify the priority areas and interaction directions in the dairy sector between China and the Russian Federation. Data and Methods. The research was conducted using the methods of comparative analysis, focusing mainly on quantitative and qualitative indicators. The conditions for the interaction of the dairy sector between China and the Russian Federation were analysed. Results. It is shown that, at present, the Chinese-Russian interaction in the dairy sector includes four aspects: trade in dairy products, experience exchange, investment cooperation and interaction at the governmental level. Trade in dairy products and the exchange of experience and technologies in the dairy sector are developing steadily, supported by increased interaction at the state level. Conclusions. The Chinese-Russian cooperation in the dairy sector is experiencing some difficulties; however, the common interest of both countries in dairy production and the strong support of both governments ensure excellent prospects for achieving mutual benefits and high performance.

scholarly journals CURRENT REQUIREMENTS FOR THE QUALITY OF HERBAL MEDICINAL PRODUCTS

2018 ◽  
Vol 8 (3) ◽  
pp. 170-178 ◽  
Author(s):  
E. I. Sakanyan ◽  
E. L. Kovaleva ◽  
L. N. Frolova ◽  
V. V. Shelestova
Keyword(s):  
Russian Federation ◽  
Herbal Medicines ◽  
The State ◽  
Arsenic Content ◽  
Medicinal Products ◽  
Herbal Products ◽  
Herbal Medicinal Products ◽  
The Russian Federation ◽  
Herbal Medicinal

The article provides the results of a comparative analysis of requirements laid out in the State Pharmacopoeia of the USSR, XI ed. (SPh XI) and the State Pharmacopoeia of the Russian Federation, XIII ed. (SPh XIII) concerning  quality evaluation and standardization of herbal substances, herbal medicines and other herbal products. The article discusses requirements  for the criteria of herbal substances and herbal medicines quality control described in general chapters and monographs that were previously in force and that have recently been adopted. The article mentions new herbal substances that were included into the State Pharmacopoeia of the Russian Federation for the first time as well as herbal substances included into the State Pharmacopoeia of the USSR, X ed., not included into SPh XI, but included into SPh XIII. The article analyses the requirements described in the new general chapters that were recently included into SPh XIII: “Herbal substances. Herbal preparations”, “Determination of heavy metals and arsenic content in herbal substances and herbal medicinal  products”, “Determination of water absorption  factor for herbal substances”,  “Buds”, “Cut-pressed granules”. The article suggests ways to improve methods of analysis of herbal substances and herbal medicinal products in view of recent advances in pharmacopoeial analysis and the increasing requirements for its quality.

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