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CHEMISTRY AND CHEMICAL ENGINEERING

DOI

10.34920/cce202239

Abstract

The aim of this study was to develop and validate the quantitative determination of titration and HPLC methods and compare them in terms of reproducibility. The development of new approaches to quality control requires the standardization of pharmaceutical products using modern methods of quantitative analysis. An HPLC method for the quantitative analysis of akonitin alkaloids has been developed and validated. Statistical processing of the obtained results showed that all the studied validation parameters are within the selected acceptance criteria, therefore, the developed method is included in the regulatory technical document Ts 03535440-017:2020 and is used in quantitative analyzes in production control. And also a comparison was made of the HPLC method with the method of anhydrous titration of alkaloids according to the Fisher criterion.

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