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Ion mobility spectrometry of talarozole, a new azole drug, in cleaning quality control
Authors:Bram Baert  Jente Boonen  Céline Thierens  Bart De Spiegeleer
Institution:1. Drug Quality and Registration (DruQuaR) group, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Harelbekestraat 72, 9000, Ghent, Belgium
Abstract:Ion mobility spectrometry (IMS) gains increased pharmaceutical interest as an analytical technique for the verification of equipment cleaning. Using a fractional factorial design, we developed an IMS method for talarozole, which represents a new generation of retinoic acid metabolism blocking agents (RAMBA) that can be used for the treatment of different dermatological diseases, such as psoriasis and acne. Using a Smiths Detection Ionscan-LS and the optimal IMS settings obtained, talarozole showed a drift time of 16.648 ms, corresponding to a reduced ion mobility K0 of 1.072 cm²V?1s?1. Total analysis times below 1 min were achieved. Talarozole was well separated in the plasmagram from other azole compounds and the limit of detection was found to be 43 ng/ml. Swab samples collected from steel and glass plates were successfully analyzed, thereby showing that IMS is indeed a suitable technique for the quantitative analysis of talarozole in cleaning quality control.
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