title: HPLC separation of acetaminophen and its impurities using a mixed-mode reversed-phase/cation exchange stationary phase.
abstract: Determination of acetaminophen and its main impurities: 4-nitrophenol, 4'-chloroacetanilide, as well as 4-aminophenol and its degradation products, p-benzoquinone and hydroquinone has been developed and validated by a new high-performance liquid chromatography method. Chromatographic separation has been obtained on a Hypersil Duet C18/SCX column, using gradient elution, with a mixture of phosphate buffer (pH = 4.88) and methanol as a mobile phase. Analysis time did not exceed 14.5 min and good resolutions, peak shapes and asymmetries have resulted. The linearity of the method has been tested in the range of 5.0-60 µg/mL for acetaminophen and 0.5-6 µg/mL for the other compounds. The limits of detection and quantification have been also established to be lower than 0.1 µg/mL and 0.5 µg/mL, respectively. The method has been successfully applied for the analysis of commercial acetaminophen preparations.
authors.affiliation: Department of Analytical Chemistry, Faculty of Chemistry, University of Bucharest, Bucharest, Romania.
authors.forename: Octavian
authors.initials: O
authors.lastname: Călinescu
authors.forename: Irinel A
authors.initials: IA
authors.lastname: Badea
authors.forename: Luminiţa
authors.initials: L
authors.lastname: Vlădescu
authors.forename: Viorica
authors.initials: V
authors.lastname: Meltzer
authors.forename: Elena
authors.initials: E
authors.lastname: Pincu
mesh_terms: D000082:Acetaminophen / Q000032:analysis* / Q000302:isolation & purification; D000083:Acetanilides / Q000032:analysis / Q000302:isolation & purification; D016227:Benzoquinones / Q000032:analysis / Q000302:isolation & purification; D002412:Cations; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002852:Chromatography, Ion Exchange / Q000295:instrumentation*; D056148:Chromatography, Reverse-Phase / Q000295:instrumentation*; D004340:Drug Contamination; D057230:Limit of Detection; D016014:Linear Models; D010636:Phenols / Q000032:analysis / Q000302:isolation & purification; D015203:Reproducibility of Results; D013607:Tablets; D013816:Thermodynamics
chemical_list: D000083:Acetanilides; D016227:Benzoquinones; D002412:Cations; D010636:Phenols; D013607:Tablets; D000082:Acetaminophen; C004532:quinone; C012241:4-chloroacetanilide