Practical application of high-performance liquid chromatography and high-performance thin-layer chromatography in pharmaceutical analysis.

Abstract

Currently, chromatographic methods are widely used to control the quality of products in the pharmaceutical and food industries. This article is devoted to the systematization of the results of scientific research of the authors on the development, validation and application of a number of chromatographic methods in the creation of generic drugs, as well as in the analysis of medicinal plant materials. The developed methods are validated according to the following parameters: specificity, linearity, accuracy and limit of detection. The specificity of the methods is based on the ability to evaluate the analyte in the presence of other components and is confirmed by using external standards. The accuracy was assessed by the results of the analysis of different weights or by the "added-found" method. For the developed methods, parameters of the suitability of chromatographic systems were established (peak symmetry factor, number of theoretical plates, relative standard deviation of retention time and peak area).