STANDARDIZATION OF A PHARMACEUTICAL SUBSTANCE WITH HYPOCHOLESTEROLEMIC ACTIVITY BASEDON BIRCH LEAVES POLYSACCHARIDES

Abstract

The development and validation of new methods to improve the reliability of drug quality control is an urgent task of pharmaceutical chemistry.The aim of the study was to improve the quality control of the substance based on birch leaves polysaccharides.Material and methods. A method of standardization of a new active pharmaceutical substance based on polysaccharides from birch leaves (Betula pendula Roth., Betula verrucosa Ehrh., Betula pubescens Ehrh), which has hypocholesterolemic activity, according to the «Quantitative determination» indicator, has been proposed. The technique is based on the quantitative determination of three major monosaccharides that make up the polysaccharide core of the macromolecule by spectrophotometry, namely: rhamnose with anthrone reagent, galacturonic acid with 3,5-dimethylphenol, and galactose with phenol. The use of the proposed integrated approach is explained by the need to improve the reliability of determining the quantitative content in order to optimize the quality control of the pharmaceutical substance. Quantitative determination of rhamnose was validated earlier [13].Results. Validation of the developed methods for the quantitative determination of glucose and galacturonic acid was carried out in terms of: specificity, linearity in the range of 0.06-0.12 mg/ml, correctness for the analytical region of 60-120% was 0.83-2.55%, repeatability 0, 6-2.16%, reproducibility 0.61-1.62%.