Исследование в области анализа мягкой лекарственной формы «Метротербиназоль», используемой в медицинской практике

Abstract

Aim. Development of a method of analysis of metronidazole and terbinafine in ointment «Metroterbinazol» using spectrophotometry. Materials and methods. A soft dosage form containing 0.1 g of metronidazole, terbinafine and 9.8 g of Tizol gel was used as the object of research. Pharmacopoeia reagents and the method of spectrophotometry were used for experimental work. Measurements were carried out on the SF-2000 spectrophotometer in the near ultraviolet region (λ = 210-340 nm). Results. To achieve this goal, we studied the electronic absorption spectra and optical characteristics of metronidazole and terbinafine in the substance, ethanol solution and in the presence of Tizol gel. The curve of ε (terb) – ε (met) to the wavelength observed a maximum at a wavelength of 223 nm, which corresponds to the maximum of absorption of terbinafine and is close to a less pronounced first absorption maximum of metronidazole (226 nm), also pronounced minimum at a wavelength of 312 nm, which is similar to the second maximum of absorption of metronidazole. The results obtained suggest that the optimal wavelengths are 223 nm and 312 nm. On an artificial mixture with a similar concentration of ingredients according to the prescription, testing was conducted for the analysis of drugs in the joint presence. As a result of experiments, it was found that the mass of metronidazole, found by the Firordt method and the simplified system of equations, is in the limit of 0.0959-0.1053 g, terbinafine – 0.1072-0.1110 g, which corresponds to the permissible deviations. Based on the research, a method for the spectrophotometric analysis of terbinafine and metronidazole in «Metroterbinazole» ointment has been developed that allows quantifying them within the permissible deviations provided for in the regulatory documentation. Conclusion. A method of spectrophotometric quantitative determination of terbinafine and metronidazole is proposed, which allows analyzing medicinal products with a relative error of ± 1.49-1.50% and establishing the quality of manufacturing of «Metroterbinazole» ointment within acceptable standards of deviations.