title: Validated liquid chromatographic method for the determination of N-3-(2,2,5,5-tetramethyl-3-pirrolin-3-carboxamidopropylphthalimide hydrochloride), a novel antiarrhythmic agent in human plasma.
abstract: A simple high-performance liquid chromatographic method with ultraviolet absorbance detection has been developed to determine the concentration of N-3-(2,2,5,5-tetramethyl-3-pirrolin-3-carboxamidopropylphthalim ide hydrochloride; A-2545), a new antiarrhythmic agent from human plasma. Separation of the investigated compound and internal standard was achieved on a Nucleosil 7 C18 column with a 0.01-M potassium dihydrogenphosphate buffer (pH 2.5)-methanol (60:40, v/v) mobile phase. The detection was performed at 220 nm. During the determinations, buspirone served as the internal standard. The compounds were isolated from plasma on a Bakerbond C18 solid-phase extraction cartridge and the mean absolute recovery was 92.9%. The limit of quantitation was found to be 10 ng/ml. The bioanalytical 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 human drug monitoring.
authors.affiliation: Haynal Imre University of Medical Sciences, Department of Internal Medicine, Budapest, Hungary.
authors.forename: K
authors.initials: K
authors.lastname: Róna
authors.forename: K
authors.initials: K
authors.lastname: Ary
authors.forename: S
authors.initials: S
authors.lastname: Ondi
authors.forename: B
authors.initials: B
authors.lastname: Gachályi
mesh_terms: D000889:Anti-Arrhythmia Agents / Q000097:blood* / Q000493:pharmacokinetics; D002065:Buspirone / Q000097:blood; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006801:Humans; D011758:Pyrroles / Q000097:blood* / Q000493:pharmacokinetics; D011786:Quality Control; D017366:Serotonin Receptor Agonists / Q000097:blood; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000889:Anti-Arrhythmia Agents; D011758:Pyrroles; D017366:Serotonin Receptor Agonists; D012996:Solutions; C109568:A 2545; D002065:Buspirone