Objective: A simple, sensitive, precise, reproducible and validated UV spectrophotometric methods have been developed for the determination of vincristine (VCR) and vinblastine (VLB) in the pure and dosage forms. Methods:The method was founded on the simple solubility of VCR and VLB in purified water, and their characteristic maximum absorption λ (max) at 295 nm and λ (max) at 268 nm for VCR and VLB respectively in the UV regions. The nature of obedience, to the Bouguer-Lambert-Beer's law by the VCR and VLB in the range of concentration 5-50 µg/ml was employed to this method.Results: Accuracy and reproducibility of the proposed method were statistically validated by recovery studies. The accuracy of the method for the VCR and VLB was ~ 100.4 % and ~ 100.32 % respectively with good reproducibility. The analytical curves were linear over a wide concentration range (5-50 µg/ml), with a correlation coefficient (r)-0.9998, and 0.9999 for VCR and VLB in that order. The method was showed sufficient precision, with a relative standard deviation (RSD) less than 1%. Conclusion:The method was validated in accordance with Russian general pharmacopoeia article (RGPA) 42-0113-09 and ICH guidelines. Validated method can easily apply for fast, precise and reliable rapid assessment of drug forms and pure substances in the laboratory.
Sea buckthorn (Hippophae rhamnoides L.) is an object of general interest due to the high content of biologically active substances (BAS). Fruits contain water- and fat-soluble vitamins, organic acids, sugars, tannins, amino acids, flavonoids and carotenoids. The latter, in turn, give the fruits a typical yellow-orange color. Carotenoids (α-, β-, and γ-carotenes) make up 11% of the unsaponifiable fraction of sea buckthorn oil and are very valuable compounds for the cosmetics industry. Leading scientists of the world have found that carotenoids have antioxidant, antimutagenic and antitumor properties, and therefore are actively used for the prevention of cancer. The fruits of sea buckthorn are the raw materials for the pharmacopeia drug - sea buckthorn oil and a large number of various herbal medicines based on it. To separate and identify complex compounds, such as carotenoids, considerable attention is paid to the TLC method. In connection with the foregoing objective of the study was the study of the TLC profile of carotenoids of sea buckthorn fruits of various varieties. Optimal chromatographic conditions were selected that ensure the best separation of carotenoid zones in a thin sorbent layer. In the used eluting system, satisfactory separation of the chromatographic zones of carotenoids is observed, since the value of sorption selectivity is greater than unity. To characterize the chromatographic profile of each variety, it is proposed to use a value of Rs that is more independent of the influence of various parameters and does not require standards. The difference in the obtained TLC profile of carotenoids of sea buckthorn fruits of representatives of ten different varieties, as well as for the fruits of a wild plant, was established. The maximum number of chromatographic zones is observed for the Ryabinovaya variety, and the minimum for the Stolichnaya variety. It was established that by the method of «fingerprints» it is possible to identify the sort of fruits of sea buckthorn by the type of chromatographic profile of carotenoids.
Objective: The aim of this work was focused on a simple, rapid, accurate and sensitive method for quantitative analysis of afobazole in microcapsules (afb-m) using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection.Methods: The analytical procedure was based on the fractionation characteristics of the afobazole in the chromatography column. The chromatography parameters «Zorbax extend-C18» column (150×2.1 mm i.d. 5 µm particle size), at 40 °C. The isocratic mobile phase was 5.0 M ammonium phosphate buffer (pH 7.0): acetonitrile (30:70; v/v) at a flow rate of at 1.0 ml. min-1. The determinations were performed using UV-Vis detector set at 220 nm.Results: An assay procedure for afb-m has been validated from indices, such as specificity, correctness, precision, and linearity. The registered retention time of the afobazole stock solution and the sample solution was 1.5 min. The determined accuracy of the method was in the range of 99.67%-100.67%. The analytical curve was linear (r2-0.9996) over a wide concentration range (50%-150%). The method showed sufficient precision, with a relative standard deviation (RSD) smaller than 2%.Conclusion: The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of afb-m. The developed assay procedure of afb-m was meeting all the requirements of ICH validation criteria and can be applied for standardisation drug form afb-m.
The purpose of the work is to study the permissible distance for the collection of medicinal plant raw materials near transport highways of different degrees of loading. The study was carried out in the Voronezh region on the example of eight different types of medicinal vegetable raw materials (Herring grass bitter, avian mountain grass, five-foot desert grass, plain thousand-year-old grass, double-ground nettle leaves, large planter leaves, common pajma flowers, core lip flowers) Collected in time of procurement along and at different distance from roads and railways of different degree of load in different natural zones, regulated by normative documentation. In the analyzed samples, the content of standardized biologically active substances, as well as heavy metals, pesticides, radionuclides, was previously estimated and full compliance with pharmacopoeia requirements was shown. In this work, the analysis was carried out on the level of ash insoluble in hydrochloric acid in the medicinal plant raw material, which makes it possible to estimate contamination of the raw material with dust particles. On the basis of the obtained data using the mathematical simulation method, the permissible distances from the transport lines, which can be recommended for the collection of safe medicinal plant raw materials, have been identified: Distance from major roads and highways loaded by road in forest natural zone conditions – at least 230 m, in forest steppe zone conditions – at least 300 m, in steppe zone conditions devoid of wood and shrub vegetation, – Not less than 660 m, near non-high-speed roads characterized by low traffic load – not less than 160 m, near railway lines – not less than 130 m. The obtained results can be recommended for safe collection of medicinal vegetable raw materials.
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