European Pharmacopoeia (Eur Ph)

Abstract The content of phenolic compounds (total phenolic compounds, tannins, flavonoids and anthocyanidins) of three species of thyme (Thymus pulegioides, Thymus pannonicus, Thymus praecox) of different origin (Bohemian-Moravian highlands, Křivoklat and Považsky Inovec) was determined using spectrophotometric methods of European Pharmacopoeia 8th edition. Furthermore, the determination of the content of essential oil and analysis of its constituents was realised. The amount of total phenolics was determined by a spectrophotometric method using the Folin-Ciocalteu reagent. Their content ranged from 3.87 to 8.86%. The content of tannins was established on a preliminary determination of the total phenolics, followed by adsorption of tannins on hide powder. The amount of tannins in our samples varied from 1.96 to 5.65%. The content of total flavonoids was determined by a spectrophotometric method using aluminium chloride. Quantitative analysis of flavonoids has shown that content in our samples ranged from 0.59 to 1.52% expressed as luteolin-7-O-glucoside (λ = 392 nm) and from 0.41 to 1.12% expressed as rutin (λ = 420 nm). Anthocyanins represent a small amount of total polyphenol content in Thymus species. In our samples, the content of anthocyanins expressed as cyanidin-3-O-glucoside varied from 0.02 to 0.1%. The determination of essential oil was realised by method of European Pharmacopoeia 8th edition. Its contents in our samples ranged from 0.2 to 0.75%. Gas chromatography-mass spectrometry was used for essential oil analysis. According to the presence of main monoterpene in Thymus essential oil, we can distinguish three chemotypes: thymol, carvacrol and linalool. Due to variations of chemical constituents of thyme essential oil, it was possible to observe a relationship between occurrence of certain chemotype and origin of sample. Differences in content of flavonoids have not shown a significant relationship to locality of origin.

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Goji Berry: Quality Assessment and Crop Adaptation of Plants Cultivated in Tuscany (Italy) by Combination of Carotenoid and DNA Analyses

Natural Product Communications ◽

10.1177/1934578x1501000660 ◽

2015 ◽

Vol 10 (6) ◽

pp. 1934578X1501000 ◽

Cited By ~ 1

Author(s):

Giada Capecchi ◽

Emanuele Goti ◽

Elena Nicolai ◽

Maria Camilla Bergonzi ◽

Roberto Monnanni ◽

...

Keyword(s):

Quality Control ◽

Dna Barcoding ◽

Analytical Methods ◽

Hplc Analysis ◽

European Pharmacopoeia ◽

Plant Adaptation ◽

Dna Analyses ◽

Berry Quality ◽

Quality Markers ◽

Crucial Information

In this study HPLC analysis for the evaluation of carotenoids and DNA barcoding are reported for three different samples of Lycium cultivated in Tuscany (Italy). These two analytical methods can represent integrative methods for quality control of goji, giving also crucial information on the plant adaptation to different environments. Hence, carotenoids represent the quality markers proposed by the monograph of the European Pharmacopoeia, while DNA barcoding can differentiate between species and populations and is useful for the detection of the homogeneity of the samples.

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Development and Validation of an UHPLC Method for Ostarine Determination in Dietary Supplements

Acta Medica Marisiensis ◽

10.2478/amma-2019-0008 ◽

2019 ◽

Vol 65 (2) ◽

pp. 49-54

Author(s):

Amalia Miklos ◽

Amelia Tero-Vescan ◽

Lénárd Farczádi ◽

Daniela-Lucia Muntean

Keyword(s):

Quantitative Determination ◽

Dietary Supplements ◽

Low Cost ◽

Reversed Phase ◽

European Pharmacopoeia ◽

Average Mass ◽

7Th Edition ◽

Development And Validation ◽

Mg Content

AbstractObjective: The purpose of this study was to develop a low-cost, yet sensitive and precise UHPLC method for the quantitative determination of ostarine from dietary supplements (DS) for athletes. The analytical performance of the method was verified on a DS legally acquired from a specialized website for athletes. The uniformity of mass and content of the ostarine DS was also verified.Methods: For the quantitative determination of ostarine a UHPLC method was developed and validated. The separation was performed using a reversed-phase C18 column, using a mixture of 75% methanol: 25% formic acid 0.1% in isocratic elution, at a flow rate of 0.5 ml/min. The uniformity of mass and content of DS was performed following the methodology described in the European Pharmacopoeia 7th Edition.Results: The validated method was specific and linear on the concentration range of 1-25 µg/ml and was precise and accurate at all concentration levels, according to the official guidelines for validating analytical methods. An average mass of 510 mg content was obtained for the ostarine capsules, with an RSD of 2.41%. Regarding the uniformity of the content, an average of 4.65 mg ostarine/capsule was obtained with an RSD of 1.05%.Conclusions: The developed UHPLC method was suitable, rapid, sensitive and allowed quantitative determination of active substance content in a DS with ostarine (92.91% ostarine/capsule from 5 mg ostarine/capsule declared by the manufacturer).

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Optimization of tablet formulation containing ginger dry extract

Current Issues in Pharmacy and Medical Sciences ◽

10.2478/cipms-2020-0018 ◽

2020 ◽

Vol 33 (2) ◽

pp. 90-93

Author(s):

Walid A.A. Malek ◽

Olena Anatoliivna Ruban ◽

Olga V. Kutova ◽

Nataliia A. Herbina

Keyword(s):

Tablet Formulation ◽

Regression Equations ◽

Diabetes Treatment ◽

Optimal Composition ◽

European Pharmacopoeia ◽

Technological Parameters ◽

Mathematical Methods ◽

Dry Extract ◽

Technical Parameters ◽

Effective Drugs

AbstractIntroduction. Diabetes mellitus is one of the world’s most common diseases, therefore the development and introduction of new effective drugs for diabetes treatment into clinical practice is an important task for the health systems of many countries of the world.Aim. The aim of our work was to determine and substantiate the quantitative ratio of excipients for the development of the optimal composition of directly compressible ginger dry extract tablets.Materials and methods. To choose the optimal composition of tablets containing ginger dry extract, the effect of various quantitative ratios of the excipients Kollidon K30 and Neusilin UFL 2 on tablet mass pharmaceutical technical parameters, determined by established methods, was studied. For processing the experimental data, mathematical methods were used: design of experiment, regression analysis and a technique based on the theory of vector optimization.Results. The interrelation between factors that were studied and technological parameters of tablet mass and compressed tablets were analyzed using regression equations.Conclusions. The studies conducted allowed to chose the optimal composition of ginger dry extract tablets: ginger dry extract – 60%, Galen IQ 721 – 34.5%, Kollidon K30 – 3.5%, Neusilin UFL 2 – 1%, calcium stearate – 1%. The chosen tablet formulation is characterized by pharmaceutical technical parameters meeting the requirements of the European Pharmacopoeia and the State Pharmacopoeia of Ukraine.

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DEVELOPMENT AND VALIDATION OF CYPHETRYLIN ASSAY IN TABLETS

Russian Journal of Biotherapy ◽

10.17650/1726-9784-2016-15-3-55-61 ◽

2016 ◽

Vol 15 (3) ◽

pp. 55-61 ◽

Cited By ~ 2

Author(s):

Z. S. Shprakh ◽

E. V. Ignatieva ◽

I. V. Yartseva ◽

N. A. Dmitricheva ◽

L. I. Smirnova

Keyword(s):

Cancer Research ◽

Potato Starch ◽

Test Validity ◽

Magnesium Stearate ◽

Somatostatin Analogues ◽

Research Center ◽

European Pharmacopoeia ◽

Intermediate Precision ◽

Is Development ◽

Development And Validation

Background. In N.N. Blokhin Russian Cancer Research Center have been synthesized a number of hypothalamic hormone somatostatin analogues, including pentapeptide cyphetrylin, and drug Cyphetrylin tablets 6 mg has been created. One of the drug standardization step is development of assay technique for acting substance in the final preparation. Objective. Development and validation of cyphetrylin assay in tablets. Materials and methods. The study used cyphetrylin, tablets 6 mg, сyphetrylin powder substance (FSBI “N.N. Blokhin Russian Cancer Research Center”, branch “Naukaprofi”), lactose monohydrate, cellulose microcrystalline, potato starch, povidone, talc, magnesium stearate (European Pharmacopoeia current edition), 95 % ethyl alcohol. Method of assay - spectrophotometry. Results. The technique for assay of сyphetrylin in drug “Cyphetrylin, tablets 6 mg” has been developed. Validation was performed to confirm test validity and accuracy. The technique was estimated by validation characteristics: specificity, linearity, accuracy, precision (repeatability and intermediate precision). Conclusion. The developed technique has the required characteristics: specificity, accuracy, repeatability, intermediate precision, linearity and can be used in the range of 70-130 % of nominal сyphetrylin content in preparation.

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