Development of two spectrophotometric methods for the determination of bilastine in tablets
DOI:
https://doi.org/10.15587/2519-4852.2026.352766Keywords:
bilastine, tablets, spectrophotometry, sulfophthalein dyes, validation, quantitative determinationAbstract
The aim of the work was to develop two simple, rapid, economically available spectrophotometric methods for the determination of bilastine in tablets based on the reaction with sulfonephthalein dyes (bromphenol blue (BPB) and thymol blue (TB)).
Materials and methods. Analytical instrumentation: Shimadzu UV-1800 double beam UV-VIS spectrophotometer (Japan) with attached UV-Probe ver. 2.62 software, RAD WAG AS 200/C precise analytical balance (Poland). Bilastine (purity ≥99% (LC)) was purchased from Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines. Nixar tablets 20 mg were purchased from a local pharmacy.
Results and discussion. Two spectrophotometric methods for the determination of bilastine in tablets have been developed. Different sulfophthalein dyes (bromphenol blue, thymol blue, bromocresol green, bromthymol blue, bromocresol purple) have been tested in order to choose the optimal reagent for the method development. The experimental research results led to the selection of BPB and TB as the reagents. Methanol was used as the solvent in reaction of bilastine with BPB, while 20% methanol-ethyl acetate solution was used for TB.
The optimal conditions for the quantitative determination of bilastine in tablets by using BPB were established: concentration – 1.08×10-3 mol/L, volume of BPB solution – 1.00 mL, wavelength – 596 nm, reaction time – 5 min, solution temperature – 25°C. The optimal conditions for the quantitative determination of bilastine in tablets by using TB were established: concentration – 4.34×10-4 mol/L, volume of TB solution – 1.00 mL, wavelength – 416 nm, reaction time – 5 min, solution temperature – 25°C.
The spectrophotometric method of the quantitative determination of bilastine in tablets by using BPB was linear in the concentration range of 0.5-7.5 μg/mL, LOD – 0.25 μg/mL, LOQ – 0.76 μg/mL; by using TB was linear in the concentration range of 2.00–18.00 μg/mL, LOD – 0.63 μg/mL, LOQ – 1.92 μg/mL. Both methods demonstrated acceptable robustness, accuracy, and precision, meeting all validation criteria. The «greenness» assessment results confirmed that both methods are excellent from a green analytical chemistry perspective.
Conclusions. The developed methods can be used as an alternative method for the routine analysis of bilastine in tablets
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