Pharmaceutical Development: Technology and Analysis of Standard Samples of Vitamins on the Model of Vitamin A
Background. The choice of the topic of this article is due to the general importance of vitamins, their serious biological role for the human and animal body, since the normal functioning of any organism is continuously associated with the receipt of a whole powerful complex of various BAS, including, above all, vitamins. Currently, the production of vitamins, especially their fat-soluble group, is characterized by certain difficulties associated with technological solutions in production and standardization issues. Purpose. The current state of the state of analysis of organic compounds categorically assumes the use of modern and promising physico-chemical methods with high accuracy and sensitivity of analysis. And this, in turn, requires the creation of standards - pure substances as a reference. However, today there are practically no domestic standard samples: standard samples of foreign pharmacopoeias dominate, and this is undoubtedly a gap in regulatory regulation, while vitamin A is especially significant at present due to the epidemic situation in the world both for medicine and pharmacy and continues to be used in food production and cosmetology. The purpose of the study is to determine the main directions of vitamin A technology, to study the stability of its standard sample under conditions of natural storage and by the method of "accelerated aging" and "stress studies". Materials and Methods. Three series of retinol palmitate were used in the experiment. Actually, stability was studied using natural storage for 12 months at a temperature of 25 °C, humidity up to 45 %, in a place protected from light. The primary packaging met the requirements of the regulatory document. In the case of "accelerated aging", the storage temperature of the material is 40 ± 2 °C, at a humidity of 75 ± 5 °C. Stress studies were conducted at a temperature of -18 °C. The frequency of control in both variants is 12 months. The experiment was carried out with constant monitoring of the parameters of the microclimate of the laboratory. The samples were analyzed by HPLC. Results. As a result, this article theoretically substantiates the fundamental possibility of obtaining a standard sample of vitamin A from a natural raw material. The shelf life of the sample was experimentally established in vivo - 1 year and with "accelerated aging" - 2 years. Conclusions. The performed studies are able to provide validation of vitamin A production and the unity of measurements related to the production of vitamins in various fields of domestic industry and agriculture.