Abstract：
:Drugs of long-term use may cause the accumulation of chemical compounds in human body. Therefore, the evaluation and structure characterization of synthesis and degradation impurities is substantial to guarantee drug safety and successful pharmaceutical therapy. The present work evaluated the anticoagulant rivaroxabana (RIV) under stress conditions in order to elucidate the chemical structure of major degradation products (DPs) formed after drug exposition to acid and alkaline hydrolysis, and UVC radiation. Analyses were performed in UPLC coupled to quadrupole time-of-flight MS. ESI was applied in positive mode, and C18 Agilent(®) column (2.1×50 mm, 1.8 μm) used for separation of compounds. RIV molecular íon [M+H](+) (m/z 436.07) was fragmented under 20 kV, best energetic condition to obtain clear and reproducible fragmentation pattern, assisting identification of RIV DPs. With support from UPLC separation and specific detection by MS/MS, three main degradation products (DP-1, DP-2, and DP-3) formed under stress conditions were successfully characterized. Presented study agrees with requirements for analytical assessment of impurities in pharmaceutical formulations, ensuring quality of pharmaceutical substances.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Wingert NR,dos Santos NO,Nunes MA,Gomes P,Müller EI,Flores ÉM,Steppe Mdoi
10.1016/j.jpba.2016.01.053subject
Has Abstractpub_date
2016-05-10 00:00:00pages
10-5eissn
0731-7085issn
1873-264Xpii
S0731-7085(16)30053-Xjournal_volume
123pub_type
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