QUALITY CONTROL OF “MEKSI-SEEM” TABLETS

Аннотация

In this article, the results of scientific research on the quality assessment of the “Meksi-SEEM” tablets recommended for use in neurological disorders are presented [1]. For the first time, the technology of coated tablets was studied based on scientific investigations. The quality indicators of the tablet were evaluated in accordance with the relevant Normative document (ND). Keywords: “Meksi-SEEM” tablets, quality indicators, appearance, identity, average weight, disintegration,quantitativeanalysis, dissolution, microbiological purity. Relevance. One of the pressing tasks for pharmaceutical specialists is to partially meet the domestic market of the Republic of Uzbekistan with high-quality, affordable, and targeted medicinal products. The development of coated tablet formulations and the improvement of their quality, as well as organizing the production of medicinal products according to Good Manufacturing Practice (GMP) guidelines, are among the crucial tasks facing local pharmaceutical enterprises. Currently, the national standard of Uzbekistan — O‘zDSt 2766:2018 “Good Manufacturing Practice (GMP)” — has expanded the opportunities for local pharmaceutical manufacturers to align their production with global standards. To evaluate the quality indicators of coated tablets, samples were taken from the finished product and tested according tothe PMrequirements. Experimental Part: First, the tablets’ appearance, organoleptic properties, were determined. Twenty tablets were taken for testing, and quality indicators were evaluated. Using a caliper, the height and diameter of the tablets were measured. The diameter of the tablets ranged from 8.99 to 9.03 mm ± 0.04 mm, and the height ranged from 3.3 to 3.4 mm ± 0.02 mm. The tablets had a uniform white color, biconvex shape, smooth and even surface, and were not stuck to each other. No excessive markings were found on the surface. The coating material was evenly distributed over the tablet core. The tablets were split in half to verify uniform coating thickness, which was confirmed. Determination of Identity: The ultraviolet absorption of the solution prepared for quantitative analysis was measured within the wavelength range of 220–380 nm. The highest absorption peaks were recorded at wavelengths of287nm and 297nm. Determination of Average Mass: The mass of uncoated and coated tablets was measured using an analytical balance with 0.001 g accuracy. The uncoated tablets weighed between 0.246–0.257 g ± 0.02 g. After coating, each of the 20 tablets was individually weighed, ranging between 0.256–0.276 g, withan average mass of0.259g. Determination of Resistance to Abrasion: To determine the resistance to abrasion, 10 uncoated tablets were taken from each sample and weighed with 0.001 g precision. The tablets were placed in a drum-type friabilator rotating 100 times within 5 minutes. After the test, the tablets were dusted andweighed again: Uncoated tablets: Ρ2 2492 = Ρ1×100 = 2508∗100 = 99.36 ≈ 99% https://ijmri.de/index.php/jmsi volume 4,issue5,2025 718 The friability of uncoated tablets was found to comply with the requirements of the Republic of UzbekistanPharmacopoeia, Chapter2.9.3.[2]. Disintegration Test: This was performed in accordance with the Uzbekistan Pharmacopoeia Chapter 2.9.1. A total of 18 tablets were tested at 37±2°C. Of these, 14 tablets began disintegrating within 20–30 minutes, while the remaining 4 started after 35 minutes. The experiment was repeated three times: in one trial, 10 tablets disintegrated in 17 minutes, 7 in 25 minutes,and 1in27minutes. The resultsmet thepharmacopeial requirements. Quantitative analysis: The content of the active pharmaceutical ingredient, ethylmethylhydroxypyridine succinate, in the coated tablets was determined by ultraviolet spectrophotometry in accordance withthe UzbekistanPharmacopoeia (2.2.25). Method Principle: Ethylmethylhydroxypyridine succinate absorbs ultraviolet light in the 284– 297 nm range. Twenty tablets were ground to a fine powder, and exactly 0.250 g of the sample was placed in a 100 ml volumetric flask. Then, 20 ml of 0.01M hydrochloric acid was added and stirred until fully dissolved. The volume was brought up to 100 ml with hydrochloric acid and filtered through filter paper (GOST 12026-76). From the filtrate, 1 ml was taken and diluted to 100 ml with 0.01M hydrochloric acid. The absorbance of the resulting solution was measured using a Beckman DU 65 spectrophotometer at a wavelength of 297±2 nm with a 10 mm cuvette. 0.01M hydrochloric acid was used as the blank solution. The absorbance of the standard solution was measured simultaneously. The content of ethylmethylhydroxypyridine succinate (X g) in one tablet was calculated using theformula: 2 1 100 100 250 X = Where: 1 100 100 1 1000 100  A₂ –optical density ofthetest solution  A₁ –optical density ofthestandard solution  M–mass ofthetest sampleingrams  P–potency (%) of thestandard ethylmethylhydroxypyridine succinate  m–m