Development of analytical methods for hydrochloride salts of cardiocyclide, a new Russian class III antiarrhythmic

Abstract

Cardiocyclide, a new Russian class III antiarrhythmic agent, was developed at the State V. V. Zakusov Science Research Institute Pharmacology, Russian Academy of Medical Sciences. The aims of the present work were to study the physicochemical properties of the hydrochloride salt of this agent (N 1 -(3-diethylaminopropyl)-N 1 -(p-nitrobenzoyl)aminoacetic acid N,N-dicyclohexylamide HCl) and to develop an analytical method for this compound. IR, 1 H NMR, and UV spectra were obtained for cardiocyclide; its solubility was studied; its melting temperature, weight loss on drying and the transparency, color, and pH of its solutions were determined. The purity of material containing compound I was determined by thin-layer chromatography; quantitative cardiocyclide contents were estimated by non-aqueous titration.

Developing methods for analysis of the solid dosage form (capsules) of cardiocyclide

“…However, the previous results indicated that processing impurities of the two last synthetic steps (II and III) in addition to unidentified impurities could not be completely separated using TLC [2]. Therefore, a decision was made to use HPLC, which is more sensitive and selective, to analyze the purity of both the drug substance and the medicinal form of I.…”

“…(100:50:3) and the method developed earlier for the drug substance of I [2]. Adsorption bands were detected using UV light at wavelength 254 nm and iodine vapor.…”

“…Steel columns (4.6 mm´150 and 250 mm) packed with C 18 sorbent (5 mm) [Luna C18 (2)] were used for the separation.…”