Foot fungus (Candida, molds, dermatophytes) is a fairly common problem. According to the WHO, one-fifth of the world’s population is affected by fungal skin diseases. The prevalence of mycosis of the feet, which affects every second person, is especially increasing. Such a pathology can appear quite unexpectedly and at an inappropriate time. Today, Ukraine is under aggressive pressure from its northern neighbor, and military personnel are not only constantly at risk of receiving combat injuries and wounds, but also due to active hostilities, they may not have access to the necessary hygiene products, get cold, overheat in the sun, or not have time to change their clothes in time. and shoes. The reality is the absence or delay of treatment; the disease progresses and can spread quickly. If mycosis has appeared in one soldier, it can quickly affect others. Therefore, the problem of providing medical and pharmaceutical care is an urgent issue today. Expanding the assortment of drugs with the above action will ensure the needs of the Armed Forces and civilian patients with this dermatological pathology. It will be able to optimize antifungal therapy regimens. For quite a long time, 1,2,4-triazole derivatives have been a promising class of organic compounds that attract the attention of scientists from various fields. It has been proven that 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol has high antifungal activity. A potential medicinal product based on this medicinal substance can be used for the treatment of various dermatological diseases. To continue the creation of new effective dosage forms for the effective therapy of mycosis of the feet, the urgent task of today is the development of an express, accurate, reliable, and affordable method of quantitative determination of the substance under study. The aim of the work is to develop an express, sensitive and easy-to-implement UV-method for the quantitative determination of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol. Materials and methods. The research object is a working standard sample of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol provided by NUNVF, LLC “Brovapharma” according to the “Research and production technological regulations for the production of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazol-4-yl)imino)methyl)phenol” developed based on scientific developed by the Ukrainian Military Medical Academy in conjunction with the National Military Medical Clinical Center “Main Military Clinical Hospital” (term of validity of the regulations until 12/31/2034). Isopropanol of grade “chemically pure” was used as a solvent. Analytical equipment: spectrophotometer Specord 200, electronic scales Radwag XA 210.4Y, class A measuring vessels. Results. An express, eco-friendly spectrophotometric method was developed for the quantification of 2-(((3-(2-fluorophenyl)-5-thio-4H-1,2,4-triazole-4-yl)imino)methyl)phenol in isopropanol area, having analytically maximum at 310 nm. The studied solutions are stable for 30 minutes. The analytical technique is linear in the range of concentrations 0.440–0.754 mg/100 ml (70–130 %). The detection and quantification limits were 5.80 % and 15.70 % respectively. The score was 0.76, according to the “greenness” icon of the analytical technique, using the tools AGREE. The prediction of the total uncertainty of the results of the developed method is 1.70 % (max∆As 2.00 %). The proposed method is relevant according to the requirements of the State Pharmacopoeia of Ukraine. Conclusions. Pharmaceutical development, introduction into industrial production and further prescribing by dermatovenerologists of an effective, safe, and harmless medicinal product will help to expand the range and reduce the level of high import dependence of the domestic market of medicinal products, which will create a more complete and balanced system of medicinal supply in Ukraine and optimize antifungal therapy schemes.
Synthetic biologically active compounds are the active pharmaceutical ingredients of various dosage forms that are widely used in both human and veterinary medicine. Nowadays the development of new effective antimicrobial and antifungal drugs remains a actual problem. This fact has a reasoned explanation in connection with the increase in infectious diseases of microbial and fungal etiology and the ever-growing resistance of microorganisms and fungi to various drugs. The aim of this research was to develop and validate a new spectrophotometric method for the quantitative determination of 4-((5-(decylthio)-4-methyl-4-H-1,2,4-triazol-3-yl)methyl)morpholine in 7% ointment by intrinsic absorption. At the stage of development of the quantitative determination method, the solvent was selected based on the solubility of the active substance. According to the data provided, 4-((5-(decylthio)-4-methyl-4-H-1,2,4-triazol-3-yl)methyl)morpholine is insoluble in water, but soluble in ethanol, methanol, isopropanol, dioxane, and dimethyl sulfoxide. Ethanol was chosen as the most accessible and less toxic solvent for the development of this method. Studied 4-((5-(decylthio)-4-methyl-4-H-1,2,4-triazol-3-yl)methyl)morpholine dissolved in ethanol is introduced into the ointment base as a solution. The quantitative content of substances subject to chemical control in soft dosage forms should be between 90% and 110% of the nominal content. On this basis, the maximum permitted analytical uncertainty can be determined, which is 3.20. During the procedure the main validation characteristics were determined, such as: linearity, precision, accuracy and robustness. Thus, a new sensitive, economical and easy-to-use spectrophotometric method for the quantitative determination of 4-((5-(decylthio)-4-methyl-4-H-1,2,4-triazol-3-yl)methyl)morpholine in a soft dosage form for external use (7% ointment) by the intrinsic absorption method was developed. According to the main validation characteristics (linearity, precision, accuracy and robustness), the proposed method is valid and meets the requirements of the State Pharmacopoeia of Ukraine.
According to statistics, craniocerebral injuries are often the cause of disability among the population. The choice of medicines for traumatic brain injuries is one of the most difficult problems in the complex treatment of such patients. Ademol (1-adamantylethyloxy-3-morpholino-2-propanol hydrochloride) is a promising medicinal substance that has a huge positive therapeutic effect of a protective act on the damaged brain and can be presented in medicinal preparations in different dosages. Therefore, the urgent task is the development of highly accurate, reliable, affordable, and fast methods of quantitative determination of ademol. The aim of the work is to study the optimal conditions for the “ademol – bromocresol green” reaction and to develop an express, sensitive and easy-to-implement method for the quantitative determination of ademol. Materials and methods. Bromocresol green (BCG) grade “chemically pure” and acetone grade “pure for analysis” were used as reagents and solvents. Analytical equipment: spectrophotometer Specord 200, electronic scales AVT-120-5DM, ultrasonic bath Elmasonic E 60H, class A measuring vessels. Results. A new method of quantitative determination of ademol by the spectrophotometric method was developed. The optimal conditions of the flow between the substance to be determined and the reagent have been studied, the concentration limits have been established, in which subordination to the basic law of light absorption is observed. A forecast of the complete uncertainty of the results of the specified method of quantitative determination was made to assess the correctness of the reproduction of the developed method in other laboratories. The proposed method is relevant according to the requirements of the State Pharmacopoeia of Ukraine. Conclusions. According to the experimental data, the method of quantitative determination of ademol can be correctly reproduced and suitable for use.
The purpose of the work was to develop of a method for the quantitative determination of piperidinium 2-[5-(2-furyl)-4-phenyl-1,2,4-triazol-3-ylthio] acetate (trifuzol) as part of a dosage form – an effervescent intrauterine suppository using spectrophotometry in the ultraviolet region spectrum and its validation according to State Pharmacopoeia of Ukraine.Materials and methods. The study was used a working standard sample of trifuzol, intrauterine effervescent veterinary suppositories, 1.0 g of trifuzol, as a solvent – purified water. Analytical equipment: Specord 200 spectrophotometer, electronic scales ABT-120-5DM, ultrasonic bath ELMASONICE 60 H, class A measuring dishes. Method of spectrophotometric analysis was used.Results. A spectrophotometric method has been developed and validated for the quantitative determination of trifuzol in a dosage form – an intrauterine effervescent veterinary suppository, based on measuring the absorption of an aqueous solution of the drug at 278 nm. The methodology tally the requirements of State Pharmacopoeia of Ukraine for such validation characteristics as specificity, linearity, precision, correctness, and robustness. The analysis of the predicted total uncertainty of the analysis was showed the reproducibility of the method and the possibility of its application in other laboratories.Conclusions. A method for the quantitative determination of trifuzol in the composition of the dosage form, an effervescent intrauterine suppository, according to the requirements of State Pharmacopoeia of Ukraine, was developed and validated. It was proved that according to such validation characteristics as linearity, specificity, precision, correctness, and robustness, the technique is correct.
The aim of this research is the development and validation of spectrophotometric methods for the determination of acetylcysteine and streptomycin sulfate, suitable for the standardization of test substances and analysis dosage forms. Materials and methods. The substances of the acetylcysteine and the streptomycin sulfate, the quinone derivatives (the solutions of sodium 1,2-naphthoquinone-4-sulfonate and 2,3-dichloro-1,4-naphthoquinone), as the analytical color reagents, were used for the experiment. The spectrophotometer Specord 200 for measuring the optical density was applied. Results. According to experimental data, the optimal conditions between the test substances and the added reagents were established. The factors affecting the character of the absorbance spectrum and the value of absorbance: the nature of the solution medium, the amount of added reagents, pH of the reaction mixture, conduction period of the reaction and reaction product resistance in time have been studied for the development of a methods of quantitative determination of acetylcysteine and streptomycin sulfate on based reactions with quinone derivatives. It was experimentally established that the sodium 1,2-naphthoquinone-4-sulfonate with streptomycin sulfate in the alkaline medium to form a colored composition with maximum light absorbance at 560 nm. The solution of 2,3-dichloro-1,4-naphthoquinone with acetylcysteine in the DMFA medium to form a colored composition with maximum light absorbance at 425 nm. It was necessary to heat it on the water bath for 10 min at 95 °С for more complete conduction period of reaction. According to SPU, the procedure of validation was determined. It has been proved that the developed techniques of the quantitative determination based on such characteristics as linearity, accuracy, validity, application range and robustness. The obedience to the Beer’s Law is 4.48–8.40 mg/100 ml for acetylcysteine and 2.00–8.00 mg/100 ml for streptomycin sulfate. Stoichiometric ratios of the reaction mixture component have been established by means of the method of isomolar series and continuous change method. Conclusion. As a result of this work, the optimal reaction conditions for the reaction of acetylcysteine with 2,3-dichloro-1,4-naphthoquinone and streptomycin sulfate with sodium 1,2-naphthoquinone-4-sulfonate have been established. Based on the obtained data, new spectrophotometric methods for the quantitative determination of the investigated drugs were developed and tested on the dosage forms. It is proved that the developed methods are simple, reproducible and expressive.
Тому метою нашої роботи стала розробка спектрофотометричної методики кількісного визначення метопрололу тартрату у субстанції та лікарських формах на основі реакції з 2,3-дихлор-1,4-нафтохіноном, який є перспективним та доступним органічним кольорореагентом. В процесі дослідження підібрані оптимальні умови проведення спектрофотометричного аналізу. Експериментально встановлено, що метопрололу тартрат реагує з 2,3-дихлор-1,4-нафтохіноном при температурі 95 °С у середовищі ДМФА з утворенням забарвленого продукту з максимумом світлопоглинання при 493 нм. Підпорядкування закону Бера перебуває у межах концентрацій 18,00–28,00 мг/100 мл. Значення межі виявлення становить 26,78 мкг/мл.