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DETERMINATION OF RESIDUAL ORGANIC SOLVENTS IN A NEW CARDIOPROTECTIVE COMPOUND BY GAS CHROMATOGRAPHY
DOI: https://doi.org/10.29296/25877313-2021-10-07
Issue:
10
Year:
2021
Relevance. Gas chromatography a method that allows you to quickly and accurately conduct a qualitative and quantitative analysis of the compo-nents of various mixtures, as well as divide them into their component parts – is widely used in various industries, including pharmaceutical. The purpose of this study was to develop and validate a method for determining residual organic solvents in the substance of the biologically active compound (BAS) N-[2-[4-oxo-3(4h)-quinazolinyl]propionyl]-guanidine (VMA-13-15) by gas chromatography. Material and methods. The objects of the study were laboratory samples of BAS VMA-13-15 (series 2017, 2018 and 2019), as well as CO methanol (GSO 8461-2003) and diethyl ether (OST-84-2006-88) qualifications of the hc. Results. A method for the determination of residual organic solvents in the BAS substance N-[2-[4-oxo-3(4h)-quinazolinyl]propionyl]-guanidine by gas chromatography has been developed. The method was validated according to the following indicators: specificity, linearity, correctness and precision. Conclusions. The method for determining the residual organic solvents of N-[2-[4-oxo-3(4h)-quinazoline]propionyl]-guanidine can be recommended for inclusion in the draft regulatory documentation
Keywords:
BAS
gas chromatography
validation
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