OPTIMIZATION OF SAMPLE PREPARATION CONDITIONS FOR DEVELOPMENT OF SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE DETERMINATION OF BISOPROLOL FUMARATE BY REACTION WITH BROMOCRESOL PURPLE IN BISOPROL TABLETS

Abstract

Introduction. Hypertension is a disease that is mostly accompanied by disability and high mortality. Having analyzed its treatment protocols, doctors prefer drugs (drugs) from the group of beta-blockers. An alternative in prescriptions is often the drug – “Bisoprol”. Although, today, various methods for its determination are known, there are a number of problems in their development; usually the tests are quite complex, take a lot of time, and require the use of expensive equipment and appropriate reagents. Also, there is a significant discrepancy with the main validation characteristics. All this suggests the relevance of developing a new method for the quantitative determination of bisoprolol, which will be fast, simple and economically feasible. Moreover, it will comply with the principles of environmental friendliness and safety. Sample preparation is a crucial stage in pharmaceutical analysis, necessary both to improve the metrological characteristics of the test, to increase accuracy, correctness, expand the range of tested concentration values, and to reduce the error of test results. Therefore, the aim of the work is to optimize the conditions of sample preparation for the development of a spectrophotometric method for the quantitative determination of bisoprolol fumarate by reaction with bromocresol purple (BCP) in “Bisoprol” tablets. The aim of the research – to optimize sample preparation conditions for the development of a spectrophotometric method for the quantitative determination of bisoprolol fumarate by reaction with bromocresol purple (BCP) in tablets. Research Мethods. Spectrophotometry was performed using a “Shimadzu UV1800” spectrophotometer (Japan) using the UVProbe 2.62 software package, quartz cuvettes (1 cm), 10 mg “Bisoprol” tablets, pharmacopoeial standard sample (PSS) of bisoprolol fumarate (“SigmaAldrich”), acetonitrile R (Sphera Seven p.d.a.), bromocresol purple (“Sigma – Aldrich”). Results and discussion. Considering the solubility of bisoprolol fumarate, the formation of its ionic associate with the BCP dye, the availability and non-toxicity of solvents, various solvents were analyzed, among which acetonitrile was selected, which has excellent properties for the absorption of the studied drug from BCP and serves as an alternative for further studies. After that, extracts from the PSZ and 10 mg Bisoprol tablets were obtained by reaction with BCP, which were later spectrophotometered and the corresponding absorption spectra were obtained. They show intensely pronounced absorption bands in the visible region of the spectrum at a wavelength of 402 nm. Also, the optimal concentrations of the prepared solutions were selected and their stability was studied. Conclusions. As a result of the conducted research, the conditions of sample preparation were optimized to develop a correct method for the quantitative determination of bisoprolol fumarate from BCP in “Bisoprol” tablets (solvent – acetonitrile R, wavelength 402 nm, optimal concentration of solutions 7.0 × 10-4 M, stability of prepared solutions for 45 minutes, which meets the requirements of the National Pharmacopoeia.