2013
DOI: 10.1002/rcm.6535
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Identification of impurities in methotrexate drug substances using high‐performance liquid chromatography coupled with a photodiode array detector and Fourier transform ion cyclotron resonance mass spectrometry

Abstract: This paper describes a HPLC-PDA/FTICR-MS method to profile and identify impurities in MTX drug substances. The results suggest that HPLC-PDA/FTICR-MS is a valuable analytical technique for the rapid identification of impurities.

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Cited by 9 publications
(10 citation statements)
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“…As a result, another 20 compounds (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) were detected, and their full-scan mass data with high-resolution and MS n data were obtained (Table 1). Their EICCs (peaks 11-30) are shown in Fig.…”
Section: Flavonoidsmentioning
confidence: 99%
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“…As a result, another 20 compounds (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) were detected, and their full-scan mass data with high-resolution and MS n data were obtained (Table 1). Their EICCs (peaks 11-30) are shown in Fig.…”
Section: Flavonoidsmentioning
confidence: 99%
“…High‐performance liquid chromatography (HPLC) coupled with mass spectrometry (MS) has become one of the most effective and powerful techniques for chemical component identification in TCMs. In recent years, hybrid high‐resolution mass spectrometry (HRMS), such as quadrupole time‐of‐flight (QTOF), ion trap time‐of‐flight (IT‐TOF), linear ion trap Fourier transform ion cyclotron resonance (LTQ/FTICR) and orbitrap mass spectrometry have become increasingly powerful tools with the advantages of excellent resolution and high mass accuracy . HRMS provides high mass accuracy, allowing the chemical formulas of detected compounds to be determined, while multiple‐stage mass data (MS n ) provide fragmentation information for predicting chemical structures.…”
mentioning
confidence: 99%
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“…Many methods based on MS/MS and HRMS technology have been developed for structural characterization of unknown compounds . Herein, data from ESI‐MS n and HRMS/MS analysis of levofloxacin were investigated in depth to better understand the relationship between structure and MS fragmentation behavior under collision‐induced dissociation (CID) conditions, and then these relationships were applied for the structural characterization of impurities.…”
Section: Resultsmentioning
confidence: 99%
“…More hyphenated techniques for identification of impurities have been reported, including liquid chromatography–diode array detection (LC–DAD), LC–mass spectrometry(LC–MS), gas chromatography–mass spectrometry (GC–MS), capillary electrophoresis–mass spectrometry, and LC–nuclear magnetic resonance (NMR) . Among these, LC–MS/MS has been the mainstay tool for identifying impurities due to its efficient separation, excellent sensitivity and selectivity, and ability to provide structure‐rich information .…”
mentioning
confidence: 99%