Создание и валидация способа количественного определения бисопролола в новой фармакологической композиции "Бисопролозоль"

Abstract

Introduction. When developing new pharmacologically active compositions and introducing them into extemporaneous manufacturing and industrial production, a comprehensive study of the properties of the medicinal product applying modern methods of analysis combining high metrological characteristics, expressiveness, sensitivity, accuracy, availability, reliability is mandatory. Development of analytical methods for quality control of new drug compositions is an urgent task of modern pharmaceutical analysis. Aim. Development and validation of a method for quantitative determination of bisoprolol in a new pharmacological composition "Bisoprolozol". Material and methods. To perform the analysis, we used pharmaceutical substance bisoprolol fumarate, glycerol hydrophilic gel "Tizol", ointment "Bisoprolozol" consisting of 0,5% of selective beta-blocker in titanium-containing glycerohydrogel. During the experiment, spectrophotometer SF-2000 and the method of absorption spectrophotometry in the ultraviolet region were used. Regression analysis of data obtained was performed in Microsoft Office Excel 2016 (OFS.1.1.0013.15 "Statistical processing of the results of chemical experiment"). The technique was evaluated according to validation parameters: specificity, linearity, correctness, and precision. Results. Studying the electronic spectral curves of bisoprolol we determined that its analysis is rationally performed at a wavelength of 274 nm (experimentally determined maximum absorption). In the course of the study we determined the sensitivity of the determination of the drug, which is equal to 5.260 µg/ml at A(min) = 0.02. The results of quantitative analysis of bisoprolol in the pharmacological composition "Bisoprolozol" showed that the mass of the selective blocker of adrenergic receptors (0.0409-0.0536 g) is within the acceptable limits according to the regulatory documentation for soft pharmaceutical forms (Order of the Russian Ministry of Health № 751n of 26.10.2015). Conclusion. In the present experiment, optimal conditions for the spectrophotometric method of analysis were selected, based on which the method of quantitative determination of bisoprolol in the new pharmacological composition "Bisoprolozol" with an error not exceeding ± 1.89 % was developed, validated and presented.