DEVELOPMENT OF THE QUANTITATIVE DETERMINATION METHOD FOR ZOPICLONE IN TABLETS BY IR SPECTROSCOPY
DOI:
https://doi.org/10.11603/2312-0967.2026.1.16020Keywords:
zopiclone, IR spectroscopy, expert examination, quantitative determination, Keywords: ticagrelor, tablets, UV-spectrophotometry, validation, nasogastral tubeAbstract
The aim of the work. To develop a simple, effective and rapid method for the quantitative determination of zopiclone in tablets by IR spectroscopy.
Materials and Methods. Zopiclone as active pharmaceutical ingredient (98.5%, "Farmak a.s.", Czech Republic, batch number 01010221), and the following tablets were used for the experimental studies: "Normason" 7.5 mg (ASTRAFARM, Ukraine) batch number – 010822, "Imovane" 7.5 mg (Sanofi, France) batch number – 1P65F, "Zopiclone-ZN" 7.5 mg (Kharkiv Pharmaceutical Enterprise "Zdorovia Narodu", Ukraine) batch number – 5321223, "Zopiclone" 7.5 mg ("Lubnypharm", Ukraine) batch number –10823, and "Sonnat" 7.5 mg ("Kyivmedpreparat", Ukraine) batch number – 0083309. An ultrasonic bath Jeken CE-7200A was used to improve the extraction of the API, and the solution was centrifuged by using an OPN-03 UKhL4.2 centrifuge. Measurements were performed on a Thermo Scientific Nicolet Apex FT-IR spectrometer equipped with Thermo Scientific OMNIC Paradigm software, using a cell with 1.0 mm solution layer thickness.
Results and Discussion. The chloroform solution of the zopiclone substance and the chloroform extract from the tablets containing zopiclone showed absorption bands in the IR spectrum in the region of 1650-1750 cm-1. LOD was 0.041 mg/mL, LOQ – 0.099 mg/mL, respectively. The regression equation was y = 2320.5x + 63.533, with a correlation coefficient of 0.9986. Linearity was observed over the entire application range of the developed quantitative determination method (0.1 – 0.9 mg/mL).
Conclusions. A quantitative determination method for zopiclone in tablets using IR spectroscopy has been developed and validated. The proposed method is rapid and efficient. Chloroform was used as the solvent. Peak area measurements were performed in the 1650-1750 cm-1 vibration regions.
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