An analytical study of 2-ethylamino-1-/3-trifluormethylphenyl/-propane (chloride fenfluramine; chloride trifluethamine)
Krácmar, J.; Cechová, J.; Alvarez Sotolongo, M.; Krácmarová, J.; Haller, A.
Ceskoslovenska Farmacie 27(10): 445-451
1978
ISSN/ISBN: 0009-0530 PMID: 36988 Document Number: 3630
Phenfluraminium chloride (formula I) as a new medicinal substance with a psychoanaleptic effect was studied from the viewpoint of its identification, follow-up of purity, and determination of content in substance and tablets. For the identification in substance, the temperature of melting with the accompanying phenomena, infrared spectrum in the tablet with potassium bromide (Graph 1), Silufol UV 254 thin-layer chromatography (Rp values in two followed systems are shown in Section 5 of the Working Methods part of the paper) and gas chromatography (Graph 4) were described. Also absorption in the ultraviolet region of the spectrum was used to characterize the substance. As follows from the typical colour curves (Graph 2 A, B) and Table 1, the medicinal substance behaves as a compound of a general spectral type: R-C,Healkyl-halogen. Also the influence of solvents on the spectrophotometric behaviour of the substance in the UV region was discussed. Thin-layer chromatography and gas chromatography wore used to follow the purity of phenfluraminitun chloride in substance. To evaluate the content of phenfluraminium in substance and tablets, spectrophotometry in the UV chloride region, titration in non-aqueous protogenic medium under visual or potontiometric control of equivalence, and gas chromatography were worked out. For the use of absorption in the UV region of the spectrum for the determination of the content, Table 1 shows specific absorbances (A 11 for the individual absorption maxima, in which an. agreement with Boer's law was verified. In Section 2 D of the Working Methods part of the paper the method of the removal of interfering absorption of the background in the evaluation of the substance in tablets was reported. Graph 3 shows the course of titration of phenfluraminium chloride in non-aqueous protogenic medium under potentiometric and visual control of equivalence with corresponding changes in colouring of crystalline violet as an indicator in the region of the point of equivalence. The results of the determination of the content of the medicinal substance in tablets and substance varied within the limits of exactness of the analytical methods used. The following tests for identification were recommended as the most suitable: in substance the determination of the temperature of melting and spectrophotometry in the infrared region, in. tablets spectrophotometry in the UV region and thin-layer chromatography. For the evaluation of the content, in substance titration in nonaqueous protogenic medium under visual or potentiometric control of equivalence, in tablets spectrophotometry in the UV region were selected as the most suitable. The methods worked out for the evaluation of the preparations Ponderal and Deobeean tablets and the substance of phenfluraminium chloride are original.
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