OPTIMIZATION OF SAMPLE PREPARATION CONDITIONS FOR THE DEVELOPMENT AND STANDARDIZATION OF A METHOD FOR THE QUANTITATIVE DETERMINATION OF BISOPROLOL FUMARATE IN TABLETS BY REACTION WITH BROMOTHYMOL BLUE
DOI:
https://doi.org/10.11603/2312-0967.2026.3.16517Keywords:
bisoprolol fumarate, bromothymol blue, sample preparation, quantitative determination, spectrophotometryAbstract
The aim of the work is the optimization of sample preparation parameters for the development of a standardized procedure for spectrophotometric determination of bisoprolol fumarate content in “Bisoprol” tablets by reaction with bromothymol blue.
Materials and Methods. The experiment was conducted using the following: a Shimadzu UV1800 spectrophotometer together with UVProbe 2.62 software package, quartz cuvettes (1 cm), 10 mg Bisoprol tablets, a pharmacopoeial standard sample of bisoprolol fumarate (“SigmaAldrich”, ≥98%, HPLC), BTS (“Sigma – Aldrich” (≥ 98%, HPLC)); acetonitrile R (“Honeywell Riedelde Haen™”, 99.9%).
Results and Discussion. Considering the structure, physicochemical properties of bisoprolol fumarate, as well as BTS, the availability and non-toxicity of extractants, it was analyzed various solvents, among which acetonitrile was selected, which exhibits excellent properties in terms of absorption of bisoprolol fumarate by the reaction of formation of ionic associates with BTS and acts as an alternative and safe reagent. After that, their acetonitrile extracts were obtained, which were spectrophotometrically measured and the corresponding absorption spectra were obtained, showing intensely pronounced absorption bands in the visible region of the spectrum at a wavelength of 400 nm, which made it possible to choose the optimal one and simultaneously determine the quantitative content of bisoprolol fumarate in the finished dosage form (tablets). Additionally, the working concentrations of the solutions were justified, and their stability over time was studied. If the latter are not stable, then further development of the method is impossible, or possible only by adding stabilizers, which will complicate the sample preparation process itself.
Conclusions. As a result of the conducted research, optimal sample preparation conditions were selected for the development of a rational and correct method for the quantitative determination of bisoprolol fumarate in “Bisoprol” tablets (solvent – acetonitrile R, final concentration of solutions 2.26 x 10-5 M with BTS (2.26 x 10-4 M)), wavelength 400 nm, stability of solutions for 45 minutes, which meets the requirements of the State Pharmacopoeia of Ukraine.
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