Detection of Xeljanz Enantiomers in Diethyl Amine Active Pharmaceutical Ingredients and Tablets. Issue 3 (29th December 2014)

• Record Type: Journal Article
• Authors: Wang, Na‐Na; Zhang, Dao‐Lin; Jiang, Xin‐Hui
• Is Part Of: Chirality. Volume 27:Issue 3(2015)
• Page Start: 235
• Page End: 238
• Publication Date: 2014-12-29
• Subjects: Chirality -- Periodicals; Pharmaceutical chemistry -- Periodicals; 541.22
• DOI: 10.1002/chir.22418
• Languages: English
• ISSNs: 0899-0042

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <p>A high‐performance <named-content content-type="chemicalTechnology" xlink:type="simple" xmlns:xlink="http://www.w3.org/1999/xlink">liquid chromatography</named-content> (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 μgmL⁻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 μgmL⁻¹. The limit of detection (LOD) and limit of quantification (LOQ) were 0.042 and 0.14 μgmL⁻¹, respectively. This HPLC method is suitable for detecting the enantiomers of Xeljanz in its APIs and tablets. <italic>Chirality 27:235–238, 2015</italic>. © 2014 Wiley Periodicals, Inc.</p> </abstract>