Department of Genetics and Bioengineering, University of Sabanci Nanotechnology Research and Application Center, 34956, Istanbul, Turkey
Hulya Yilmaz is affiliated to Department of Genetics and Bioengineering. He is a recipient of many awards and grants for his valuable contributions and discoveries in major area of subject research. His international experience includes various programs, contributions and participation in different countries for diverse fields of study. His research interests reflect in his wide range of publications in various national and international journals.
Research Article
Forced Degradation Studies to Assess the Stability of a Janus Kinase Inhibitor Using RPLC Method
Author(s): Hulya Yilmaz*
In optimization studies, it is important to study the retention behavior of the compounds containing the ionizable functional groups under the intended chromatographic conditions. In this study, the influence of pH and acetonitrile (ACN) composition in the mobile phase on chromatographic behavior of tofacitinib (TOF), a Janus kinase (JAK) inhibitor, was investigated in details. First, the chromatographic conditions were optimized using retention factors and pKa values. Then, the developed method was used for the stability studies under various stress conditions, and for the estimation of TOF concentration in tablets. Finally, the method was validated using the International Conference on Harmonization (Q2) guidelines and it was successfully used to separate the TOF degradation products. A linearity range, limit of detection and limit of quantification were determined as 2.0-12.0, 0.41.. View more»