Academic Journal
Development, Validation and Approbation Analytical Method for the Quantitative Determination of Taurine by HPLC-UV Method in the Test of Comparative Dissolution Kinetics ; Разработка, валидация и апробация аналитической методики количественного определения таурина методом ВЭЖХ-УФ в рамках проведения теста сравнительной кинетики растворения
| العنوان: | Development, Validation and Approbation Analytical Method for the Quantitative Determination of Taurine by HPLC-UV Method in the Test of Comparative Dissolution Kinetics ; Разработка, валидация и апробация аналитической методики количественного определения таурина методом ВЭЖХ-УФ в рамках проведения теста сравнительной кинетики растворения |
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| المؤلفون: | A. M. Poluyanov, A. Kochug, L. S. Mitrofanova, I. D. Nikitin, O. Yu. Vergasov, I. E. Shohin, E. N. Fisher, А. М. Полуянов, А. Кочуг, Л. С. Митрофанова, И. Д. Никитин, О. Ю. Вергасов, И. Е. Шохин, Е. Н. Фишер |
| المصدر: | Drug development & registration; Том 12, № 2 (2023); 62-72 ; Разработка и регистрация лекарственных средств; Том 12, № 2 (2023); 62-72 ; 2658-5049 ; 2305-2066 |
| بيانات النشر: | LLC «CPHA» |
| سنة النشر: | 2023 |
| المجموعة: | Drug development & registration (E-Journal) / Разработка и регистрация лекарственных средств |
| مصطلحات موضوعية: | валидация, HPLC-UV, taurine, 4-toluenesulfonyl chloride, derivatization, validation, ВЭЖХ-УФ, таурин, 4-толуолсульфонилхлорид, дериватизация |
| الوصف: | Introduction. Taurine is a non-proteinogenic amino acid. The molecule is involved in lipid metabolism, adsorbs fat-soluble vitamins, and its conjugates with bile acids contribute to the emulsification of fats in the intestine. Drugs, which include a taurine molecule, have anti-cataract, cardiotonic, metabolic effects, and also stimulate regeneration. Among the dosage forms, where taurine acts as an active substance, there is a solid dosage form – film-coated tablets. One of the methods for assessing the quality of solid dosage forms is a comparative dissolution kinetics test. High-performance chromatography with ultraviolet detection is a widely used method for quantification within the dissolution test, however, for taurine, which does not contain chromophore groups in its structure, this method is not directly applicable. To solve this problem, one can apply the method of pre-column derivatization, because of which an fragment is introduced into the structure, providing a bathochromic shift in the UV spectrum of the starting compound.Aim. Development, validation and approbation analytical method for the quantitative determination of taurine by high-performance chromatography with ultraviolet detection as part of a test comparative kinetics dissolution of taurine tablets with a dosage of 250 and 500 mg.Materials and methods. The following preparations were used for the analysis: taurine tablets, film-coated 250 mg and 500 mg, domestic production with a valid expiration date. The comparative dissolution kinetics test was carried out on a DT 126 Light instrument for the "Dissolution" test (ERWEKA GmbH, Germany). Chromatographic separation and detection were performed on a Nexera-i LC-2040 high-performance liquid chromatograph (Shimadzu Corporation, Japan) equipped with a column and sample thermostat, a degasser, an autosampler, and an ultraviolet detector. Detection was carried out at a wavelength of 254 nm after derivatization of the taurine molecule with 4-toluenesulfonyl chloride. Were used a Shim-pack Velox ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | Russian |
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| DOI: | 10.33380/2305-2066-2023-12-2-62-72 |
| الاتاحة: | https://www.pharmjournal.ru/jour/article/view/1483 https://doi.org/10.33380/2305-2066-2023-12-2-62-72 |
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| رقم الانضمام: | edsbas.1CEE2A0F |
| قاعدة البيانات: | BASE |
| DOI: | 10.33380/2305-2066-2023-12-2-62-72 |
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