Articles

Yegorova А.V., Scrypynets Yu.V., Fedosenko G.O., Maltsev G.V., Kashutskiy S.M. Practical application of high-performance liquid chromatography and high-performance thin-layer chromatography in pharmaceutical analysis

UDC: 543.544:615.07M
DOI: 10.15407/zht2021.67.046

article

Yegorova A.V., Scrypynets Yu.V., Fedosenko G.O., Maltsev G.V., Kashutskiy S.M.

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

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). HPLC methods have been developed for the determination of active substances in combined preparations, for the study of dissolution profiles, and the determination of residual amounts of drugs on the surfaces of pharmaceutical equipment. The HPTLC methods for determining the residual amounts of plant materials – dry extract of ginkgo biloba leaves (by quercetin content) and curcumin in “Gallina Blanca” bouillon cubes are proposed. The proposed methods are characterized by satisfactory metrological characteristics and ease of analysis.
Key words: high-performance liquid chromatography, high-performance thin-layer chromatography, validation, active pharmaceutical ingredient.

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