VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR QUANTIFICATION OF BIRCH POLYSACCHARIDES

Abstract

The development of methods for the quantitative determination of active pharmaceutical substances planned to be included in the regulatory documentation requires validation activities. This article presents the results of the validation of a spectrophotometric method for the quantitative determination of birch leaves polysaccharides (PSBl) with lipid-lowering activity. The proposed method is distinguished by specificity, linearity (0.04-0.12 mg / ml), correctness in the range of contents of 75-120% (2.8-4.1%) and precision under repeatability conditions (0.25-0.44 %) and reproducibility (0.44-0.89%). Thus, the suitability of the technique for quantitative spectrophotometric determination of PSBl for inclusion in the regulatory documentation for a substance being developed is shown.