DEVELOPMENT OF THE UV-SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATIVE DETERMINATION OF LEVOCETIRIZINE IN TABLETS FROM THE POSITION OF THE “GREEN” CHEMISTRY PRINCIPLES
DOI:
https://doi.org/10.11603/mcch.2410-681X.2024.i3.14932Keywords:
spectrophotometry, quantification, validation, levocetirizineAbstract
Introduction. Levocetirizine is the R-enantiomer or active isomer of cetirizine, which is often used to treat allergic reactions. Scientific sources mainly describe methods by using differential spectrophotometry, high-performance liquid chromatography, which require expensive equipment, complex mathematical calculations and do not always comply with environmental safety. Whereas, spectrophotometry in the UV region belongs to the pharmacopoeial methods of analysis, which has a number of advantages: rapidity, economy, low cost and it is widely used in the analysis of medicines.
The aim of the work – to develop a simple, express, “green”, inexpensive UV-spectrophotometric method for the quantitative determination of levocetirizine in tablets.
Research Methods. A pharmacopoeial standard sample (PSS) of levocetirizine dihydrochloride and "Alerzin" 5 mg tablets (manufacturer: Egis, Hungary), batch number 3161C0722, were used for the experimental studies. Spectrophotometric measurements were carried out by using a Shimadzu UV-1800 double-beam scanning spectrophotometer (Japan) with UV-Probe 2.62 software.
Results and Discussion. The ethanol solution of the pharmacopoeial standard sample (PSS) of levocetirizine dihydrochloride and the ethanol solution of the tablets containing levocetirizine dihydrochloride have intensely expressed absorption band with a maximum at a wavelength of 233 nm. LOD was 1.02 μg/mL, LOQ – 3.39 μg/mL, respectively. The regression equation was also presented as y = 0.0261х–0.0697 and the correlation coefficient (R2=0.9993) was calculated. Linearity was observed over the entire application range of the developed quantitative determination method (9.24–36.97 μg/mL). The evaluation of the proposed methodology “greenness” indicates that the analytical technique is excellent according to the “green” chemistry principles.
Conclusions. An UV-spectrophotometric method of quantitative determination of levocetirizine in tablets has been developed, which is express enough and “green”. Ethanol was used as a solvent. Measurement of ethanol solution absorbance must be carried out at a wavelength of 233 nm.
References
Izadi, N., & Saff, R.R. (2022). Allergy and immunology interest and exposure among US medical students and residents. Journal of Allergy and Clinical Immunology: Global, 1(4), 305-308.
Dierick, B.J., van der Molen, T., Flokstra-de Blok, B.M., Muraro, A., Postma, M.J., Kocks, J.W., & van Boven, J.F. (2020). Burden and socioeconomics of asthma, allergic rhinitis, atopic dermatitis and food allergy. Expert review of pharmacoeconomics & outcomes research, 20(5), 437-453.
Denton, E., & Bousquet, J. (2022). Quality of life in combined asthma and rhinitis: the impact of sniff, sneeze, and wheeze. The Journal of Allergy and Clinical Immunology: In Practice, 10(3), 853-854.
Klymenko, V.A., Karpushenko, Yu.V., Kulik, T.V., Ashcheulov O.M. (2022). Observation of a patient with allergic rhinitis in Ukraine: international recommendations and own experience. Asthma and Allergy, (3), 33–40. [in Ukrainian].
Charoo, N.A., Abdallah, D.B., Ahmed, D.T., Abrahamsson, B., Cristofoletti, R., Langguth, P., ... & Dressman, J. (2023). Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Levocetirizine Dihydrochloride. Journal of Pharmaceutical Sciences, 112(4), 893-903.
Labib, G.S. (2015). Novel levocetirizine HCl tablets with enhanced palatability: synergistic effect of combining taste modifiers and effervescence technique. Drug design, development and therapy, 5135-5146.
Levocetirizine. https://www.drugbank.ca/drugs/DB06282
European Pharmacopoeia. 11 ed. (2022). https://www.edqm.eu/en/european-pharmacopoeia-ph.-eur.-11th-edition
United States Pharmacopeia (USP). (2023). https://www.usp.org
State Pharmacopoeia of Ukraine: in 3 vol. (2015). State Enterprise “Ukrainian Scientific Pharmacopoeia Center for the Quality Medicines” [in Ukrainian].
Gałuszka, A., Migaszewski, Z.M., Konieczka, P., & Namieśnik, J. (2012). Analytical Eco-Scale for assessing the greenness of analytical procedures. TrAC Trends in Analytical Chemistry, 37, 61-72.
Pena-Pereira, F., Wojnowski, W., & Tobiszewski, M. (2020). AGREE—Analytical GREEnness metric approach and software. Analytical chemistry, 92(14), 10076-10082.
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