Development of an Optimal Method for the Quantitative Determination of 1-(ß phenylethyl)-4-amino-1,2,4-triazolium Bromide in a solution for Injection

Cardiovascular diseases are currently the leading cause of death and disability worldwide. Each year, their prevalence and severity continue to grow. As a result, developing new treatments and preventive measures for cardiovascular conditions has become a critical focus in medicine and pharmacy today. Today, drugs in the form of injections are used in most cases for the treatment of patients in hospital conditions. Therefore, an injectable dosage form was created for the new original compound of 1-(β-phenylethyl)-4-amino-1,2,4-triazolium bromide, which exhibits antihypertensive, antiischemic, and antioxidant properties. The purpose of our work is to develop an optimal method for the quantitative determination of 1-(ß-phenylethyl)-4-amino-1,2,4-triazolium bromide in an injectable dosage form by the method of high-performance liquid chromatography (HPLC). During the research, we used a laboratory sample of a solution for injections with a concentration of 5 mg/ml, the active ingredient is 1-(ß-phenylethyl)-4-amino-1,2,4-triazolium bromide. A standardized substance of 1-(ß-phenylethyl)-4-amino-1,2,4-triazolium bromide with a content of 99.95% was used as a working standard sample. The research was carried out on the basis of the chemical and physical control laboratory of the Technical Control Department, SE "Chemical Reagent Plant" (city of Kharkiv). The main stage of the work was the development of the method of standardization of the active substance by the HPLC method. As a result of the conducted research, an eluent and a column were selected, with the help of which, under certain conditions, it is possible to carry out simultaneous identification and quantitative determination. According to the developed methods, we analyzed all the series prepared in laboratory conditions. During the work, the content of 1-(ß-phenylethyl)-4-amino-1,2,4-triazolium bromide in the injection solution was determined, which is in the range from 4.83 to 5.25 mg in 1 ml. According to the demands of the State Pharmacopoeia of Ukraine, the content of 1-(ß-phenylethyl)-4-amino-1,2,4-triazolium bromide in the injection solution should be from 4.5 mg to 5.5 mg in 1 ml. As can be seen from the above data, the obtained results meet all the demands of the State Pharmacopoeia of Ukraine. Thus, in the course of the work, a method was developed for the quantitative determination of 1-(ß-phenylethyl)-4-amino-1,2,4-triazolium bromide in an injectable dosage form using the HPLC method. The developed method is planned to be used for continuous quality control of the developed dosage form.