DEVELOPMENT OF THE UV SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF ENALAPRIL MALEATE IN TABLETS USING THE PRINCIPLES OF GREEN CHEMISTRY
DOI:
https://doi.org/10.11603/mcch.2410-681X.2024.i2.14777Keywords:
spectrophotometry, enalapril maleate, validation, quantification, tabletsAbstract
Introduction. There are many spectrophotometric methods available in the scientific literature for the quantitative determination of enalapril maleate in mono- and combination medicinal products. However, it should be noted that not all developed methods meet the validation characteristics, set of guidelines and quality standards that would indicate their high efficiency and safety. Therefore, there is a need to develop modified, easy-to-use, rapid and environmentally friendly methods for the quantitative determination of enalapril maleate in tablets
The aim of the study – to develop a rapid, simple, «green» and economical UV- spectrophotometric method for the quantitative determination of enalapril maleate in tablets.
Research Methods. For the study, a pharmacopoeial standard sample of enalapril maleate (Sigma- Aldrich, purity 98.9 %), methanol P (“Honeywell Riedel-de Haen™”, 99.9 %), 10 mg tablets (from two different manufacturers) were used. The optical density in the UV region was measured using a Shimadzu UV-1800 spectrophotometer (Japan) in quartz cuvettes with a layer thickness of 1 cm. The UV-Probe 2.62 software package was used to process the obtained spectra.
Results and Discussion. The absorbance spectra of methanol extracts from enalapril maleate tablets and enalapril maleate FSS in methanol have pronounced absorption maxima at 212 nm. The regression equation was obtained – y = 0.0264x – 0.0641 and the correlation coefficient was 0.9996. The linearity parameters met all the requirements of the PFC over the entire range of application (14–26 µg/ml). The limit of detection of enalapril maleate was 0.60 µg/ml and the limit of quantification was 1.81 µg/ml. The systematic error of this method is δ % = 0.09, which indicates a sufficient closeness of the average result of the obtained optical density to the nominal value. During the study of the robustness of the method, it was found that the studied solutions were stable for 120 min. The environmental friendliness of the method was calculated using the AGREE method and the analytical eco-scale. The proposed UV-spectrophotometric method for the determination of enalapril maleate meets all the principles of «green» chemistry.
Conclusions. An express, simple, “green” and economical UV-spectrophotometric method for the quantitative determination of enalapril maleate in tablets using methanol as a solvent with an absorbance maximum at 212 nm was developed. The proposed UV-spectrophotometric method was successfully applied to determine the quantitative content of enalapril in tablets.
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