Year: 2025
Type: article
Abstract: A new TLC method combined with densitometry was developed for the determination of donepezil hydrochloride in Cogiton Biofarm and Donecept Actavis tablets. The analyses were performed on TLC silica gel 60F254 plates with mobile phase of n-butanol + n-propanol + acetone + water + glacial acetic acid at ratio of 2:2:1:1:1, v/v. The proposed mobile phase is miscible and after development the chromatographic plate has a homogeneous background in visible light. Densitometric analysis at λ = 319 nm was used for quantitative studies. The method was linear from 1.0 to 5.0 µg/spot and from 0.2 to 1.0 µg/spot and it was validated for both concentration ranges. The presented method is rapid, selective, linear, accurate, precise, robust, and economical. The results of the donepezil content in drugs calculated from both calibration curves were that no statistically significant differences were observed. The obtained content of donepezil in Cogiton (99.2%) and Donecept (99.0%) tablets is within the deviations permitted by the European Pharmacopoeia in relation to the amount declared by the manufacturer. The novelty of the study consists of the development of chromatographic conditions allowing the separation of as many as six donepezil degradation products with the simultaneous use of TLC chromatographic plates. As a result, the proposed method is economical, since it is several times cheaper than using HPTLC plates. While Ali et al. separated a maximum of three degradation products from donepezil, Pandey et al. successfully separated only two donepezil-related substances from donepezil. The proposed new TLC method combined with densitometry can be used for the routine control of donepezil in pharmaceutical preparations (tablets). Since TLC is less sensitive and precise compared to HPLC, it can be used as a complementary technique.
Source: Processes
DOI: 10.3390/pr13041106
Authors: Wioletta Parys, Alina Pyka-Pająk
Institution: Medical University of Silesia
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $2,896
Award: G5067829471
OpenAlex ID: W4409713754