Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki (Mar 2019)
Regarding the standardization of L-arginine and thiotriazoline in the model mixture by high-performance liquid chromatography
Abstract
Today, one of the main causes of disability and mortality in the world's population is the disease of the cardiovascular and central nervous systems. Therefore, the development of new highly effective drugs for their treatment becomes an urgent task of modern medicine and pharmacy. Promising in this direction is the creation of a new medicinal product, which combines the active donor NO – neurotransmitter amino acid L-arginine, as well as the famous domestic antioxidant – thiotriazoline. A rational dosage form – pills was chosen to create a new combined drug. Therefore, the actual and timely task is to develop methods for standardizing the active substances in the model mixture, which in future can become the basis for the analysis of the finished dosage forms of the new drug. The purpose of the work is to develop a method for standardizing the model mixture of L-arginine and thiotriazoline in the ratio of 4:1 by HPLC method. Materials and methods. During the research, certified substances L-arginine (manufacturer: Sigma-Aldrich, USA) and thiotriazolin (manufacturer State Enterprise “Chemical Reagents Plant” of the Scientific-Technological Complex “Institute of Single Crystals” of the National Academy of Sciences of Ukraine) were used. The research was carried out using LC-20 Prominence Shimadzu Chromatograph. Results. First, in the laboratory, six series of model mixture of L-arginine and thiotriazoline were produced in an optimum ratio of 4:1. Continuously, the test solution and the solution of the working standard sample, were chromatographed obtaining at least three chromatograms for each solution. It is established that the content of L-arginine in the model mixture ranges from 198.38 mg to 200.66 mg, and thiotriazoline is from 50.82 mg to 51.61 mg. According to the content of the active substances, the studied series of model mixture of L-arginine and thiotriazoline in a ratio of 4:1 correspond to the requirements of the SPF. Conclusions. In the course of the conducted researches the method of standardization of active substances of the model mixture of L-arginine and thiotriazoline in a ratio of 4:1 by the HPLC method, which is reproducible, accurate and can be used later in the quality control of the established tablet formulation, has been developed.
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