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Detection of Xeljanz Enantiomers in Diethyl Amine Active Pharmaceutical Ingredients and Tablets
Author(s) -
Wang NaNa,
Zhang DaoLin,
Jiang XinHui
Publication year - 2015
Publication title -
chirality
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.43
H-Index - 77
eISSN - 1520-636X
pISSN - 0899-0042
DOI - 10.1002/chir.22418
Subject(s) - chemistry , chromatography , enantiomer , detection limit , diethylamine , high performance liquid chromatography , active ingredient , hexane , amine gas treating , isopropyl alcohol , organic chemistry , pharmacology , medicine
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. Chirality 27:235–238, 2015 . © 2014 Wiley Periodicals, Inc.