高效液相色谱和高效薄层色谱在药物分析中的实际应用。

A. Yegorova, Y. Scrypynets, G. Fedosenko, G. Maltsev, S. Kashutskiy
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引用次数: 0

摘要

目前,色谱法在制药和食品行业被广泛用于控制产品质量。本文致力于系统化作者在开发、验证和应用多种色谱方法开发仿制药以及分析药用植物材料方面的科学研究结果。根据以下参数对所开发的方法进行了验证:特异性、线性、准确性和检测限。该方法的特异性基于在存在其他成分的情况下评估分析物的能力,并通过使用外部标准进行确认。准确性通过不同权重的分析结果或“添加-发现”方法进行评估。对于所开发的方法,建立了色谱系统适用性的参数(峰对称因子、理论板数、保留时间和峰面积的相对标准偏差)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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).
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