VALIDATED LIQUID-CHROMATOGRAPHIC METHOD FOR THE DETERMINATION OF RAMETHYL-3-PIRROLIN-3-CARBOXAMIDOPROPYLPHTHALIMIDE HYDROCHLORIDE), A NOVELANTIARRHYTHMIC AGENT IN HUMAN PLASMA

A simple high-performance liquid chromatographic method with ultraviol et absorbance detection has been developed to determine the concentrat ion of amethyl-3-pirrolin-3-carboxyamidopropylphthalimide hydrochlorid e; A-2545), a new antiarrhythmic agent from human plasma. Separation o f the investigated compound and internal standard was achieved on a Nu cleosil 7 C-18 column with a 0.01-M potassium dihydrogenphosphate buff er (pH 2.5)-methanol (60:40, v/v) mobile phase. The detection was perf ormed at 220 nm. During the determinations, buspirone served as the in ternal standard. The compounds were isolated from plasma on a Bakerbon d C-18 solid-phase extraction cartridge and the mean absolute recovery was 92.9%. The limit of quantitation was found to be 10 ng/ml. The bi oanalytical method was validated with respect to linearity, within-and between-day accuracy and precision, system suitability and stability. All validated parameters were found to be within the internationally required limits. The developed analytical method for A-2545 was found to be suitable for application in pharmacokinetic studies and for huma n drug monitoring. (C) 1998 Elsevier Science B.V.