title: Detection of Xeljanz enantiomers in diethyl amine active pharmaceutical ingredients and tablets.
abstract: A high-performance liquid chromatography (HPLC) method was established to detect Xeljanz enantiomers in active pharmaceutical ingredients (APIs) and tablets. The separation was achieved on a Chiralpak IC column using a mobile phase of hexane-ethanol-diethylamine (65:35:0.1, v/v). The detection wavelength was 289 nm. The peak areas and the enantiomer concentrations in the range of 0.15-2.25 μg•mL(-1) were in high linearity, with correlation coefficients higher than 0.999. The recoveries were 86.44% at the concentrations of 7.5, 18.75, and 37.5 μg•mL(-1) . The limit of detection (LOD) and limit of quantification (LOQ) were 0.042 and 0.14 μg•mL(-1) , respectively. This HPLC method is suitable for detecting the enantiomers of Xeljanz in its APIs and tablets.
authors.affiliation: Pharmacy School of Chongqing Medical University, Yuzhong District, Chongqing, P.R. China.
authors.forename: Na-Na
authors.initials: NN
authors.lastname: Wang
authors.forename: Dao-Lin
authors.initials: DL
authors.lastname: Zhang
authors.forename: Xin-Hui
authors.initials: XH
authors.lastname: Jiang
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004048:Diethylamines / Q000032:analysis*; D053616:Janus Kinase 3 / Q000037:antagonists & inhibitors*; D010880:Piperidines / Q000032:analysis*; D047428:Protein Kinase Inhibitors / Q000032:analysis*; D011743:Pyrimidines / Q000032:analysis*; D011758:Pyrroles / Q000032:analysis*; D013237:Stereoisomerism; D013607:Tablets
chemical_list: D004048:Diethylamines; D010880:Piperidines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D011758:Pyrroles; D013607:Tablets; C479163:tofacitinib; C034281:diethylamine; D053616:Janus Kinase 3
keywords: Xeljanz enantiomers; chiral separation; detection; high-performance liquid chromatography