title: Rapid detection and identification of impurities in ten 2-naphthalenamines using an atmospheric pressure solids analysis probe in conjunction with ion mobility mass spectrometry.
abstract: The atmospheric pressure solids analysis probe (ASAP), in conjunction with ion mobility time-of-flight mass spectrometry (IM-ToF-MS), has been applied to the impurity profiling study of ten 2-naphthalenamines. The impurity profiles achieved by ASAP-IM-MS were compared with those obtained by liquid chromatography-electrospray ionisation-mass spectrometry (LC-ESI-MS). All the impurities at the level of 0.1 area % and above, except for one, detected by LC-ESI-MS, were also found by ASAP-IMS analyses. In addition, one non-polar compound was detected by ASAP-IM-MS alone. The IM-MS plot of ion drift time versus m/z values offered sufficient separation between the impurities with different m/z. Therefore, instead of LC as a separation tool, IM-MS is able to provide fingerprint profiling for the ten samples analysed. The time of each analysis has been reduced from 25 min by LC-MS to less than 3 min by ASAP-IM-MS. When collision energy was applied for the selected precursor ion in the transfer T-wave, a clean MS/MS spectrum was obtained for structural elucidation of unknown impurities. The hyphenation of ASAP and IM-MS techniques represents a highly efficient approach for rapid detection and identification of impurities generated in complex reactions involved in pharmaceutical development.
authors.affiliation: AstraZeneca R&D, Department of Analytical Science, Pharmaceutical Development, 151 85 Södertälje, Sweden. hefeng.pan@astrazeneca.com
authors.forename: Hefeng
authors.initials: H
authors.lastname: Pan
authors.forename: Göran
authors.initials: G
authors.lastname: Lundin
mesh_terms: D001274:Atmospheric Pressure; D004340:Drug Contamination; D004341:Drug Evaluation / Q000379:methods*; D007477:Ions; D013058:Mass Spectrometry / Q000379:methods*; D009281:Naphthalenes / Q000032:analysis* / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000737:chemistry*
chemical_list: D007477:Ions; D009281:Naphthalenes; D004364:Pharmaceutical Preparations