A study on structural characterization of degradation products of cangrelor using LC/QTOF/MS/MS and NMR
[Display omitted] •Cangrelor was subjected to acid, base and peroxide stress conditions.•Acid and peroxide sensitive hydrolysis resulted in formation of six degradation products.•Structures of all the six degradation products were established by extensive characterization of LC/QTOF/MS/MS and NMR.•L...
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Veröffentlicht in: | Journal of pharmaceutical and biomedical analysis 2019-06, Vol.170, p.327-334 |
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Format: | Artikel |
Sprache: | eng |
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•Cangrelor was subjected to acid, base and peroxide stress conditions.•Acid and peroxide sensitive hydrolysis resulted in formation of six degradation products.•Structures of all the six degradation products were established by extensive characterization of LC/QTOF/MS/MS and NMR.•Liquid chromatography method compatible with mass spectrometry was developed.•Mass fragmentation pathway was established for the cangrelor and degradation products.
A complete degradation study was performed on cangrelor drug substance as per the ICH guidelines. The study reveals that a total of six degradation products (DP-1 to DP-6) were found and out of these, three unknown degradation products (DP-1, DP-5 and DP-6) were not reported in the literature. Based on the degradation study, the drug substance cangrelor was found to be sensitive towards acidic, basic and oxidative conditions. Besides, it was stable under thermal and photolytic stress conditions. The degradation products were characterized by using advanced LC/QTOF and MS/MS analysis. Further, the structures were characterized by NMR studies. The identified degradation products of cangrelor are valuable for cangrelor manufacturing process and quality control. |
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ISSN: | 0731-7085 1873-264X |
DOI: | 10.1016/j.jpba.2019.03.031 |