Standardization of the Pharmaceutical Substance of the Silicon-zinc-boron-containing Glycerohydrogel

Abstract

Introduction. Silicon-zinc-boron-containing glycerohydrogel substance is considered as a pharmaceutical substance for the new drugs creation with antimicrobial action for local, external and intravaginal use. Standardization and validation of the methods determining the quality parameters of the corresponding substances is one of the stages of introducing new pharmacologically active compounds into practice.Aim. Determine the quality parameters of silicon-zinc-boron-containing glycerohydrogel, conduct their approbation. Develop a method for quantitative determination of silicon, zinc and boron. Perform statistical results processing of quantitative determination and provide a validation assessment of the chosen method.Materials and methods. A silicon-zinc-boron-containing glycerohydrogel substance was synthesized at the Institute of Organic Synthesis of the Ural Branch of the Russian Academy of Sciences and was used as the studying object. The studies were performed using a Nicolet 6700 (Thermo Fisher Scientific, USA) spectrometer and an OPTIMA 4300 DV (PerkinElmer, США) optical emission spectrometer with inductively coupled plasma.Results and discussion. The paper describes the results of new pharmacologically active silicon-zinc-boron-containing glycerohydrogel substance qualitative and quantitative tests. The data of statistical processing and validation assessment of the quantitative determination of silicon, zinc, and boron are presented.Conclusion. The quality parameters of silicon-zinc-boron-containing glycerohydrogel were determined. A method of silicon, zinc and boron quantitative determination was developed. Standardization of the investigated pharmacologically active substance was carried out in accordance with the current requirements for pharmaceutical substances in the Russian Federation.