QUANTITATIVE DETERMINATION OF THE ALKALOID DONAXIN IN THE SUBSTANCE DONAXINE HYDROCHLORIDE

Abstract

The development of analytical methods for the standardization of a substance, as well as dosage forms based on it, is an actual task in the production of pharmacological preparations. In connection with the increasing requirements for the quality of active pharmaceutical ingredients, it is advisable to include modern chromatographic methods (HPLC and GLC) in them. In addition, the prospect of introducing drugs into medical practice determines the need to develop highly sensitive methods for determining active substances in substances for pharmacokinetic studies. The aerial part of Arundo donax L. is the main raw material for the industrial production of the drug substance Donaxin hydrochloride. Donaxin is an alkaloid of the indole group and has the chemical structure of 3-(dimethylaminomethyl) indole. Previously, for the quantitative determination of donaxin hydrochloride in the substance of the drug of the same name, the titrometry method was used, according to the results of which the content of the active substance was at least 98.0%. The aim of this study was to develop and validate a new modern technique that exceeds the titration method in selectivity, reproducibility and precision. We have developed and validated a new method for the quantitative determination of Donaxin hydrochloride using high performance liquid chromatography (HPLC). This technique is simple and well reproduced. The developed method was validated according to the following indicators: specificity, linearity, precision, limit of detection and limit of quantitation. A comparative evaluation of the developed method for the quantitative determination of Donaxin hydrochloride in the substance by HPLC with the method included in the temporary pharmacopoeia article (titrimetric) was carried out in terms of the Fisher criterion.