Identification and structure elucidation of a new degradation impurity in the multi-component tablets of amlodipine besylate
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu časopisecké články
PubMed
30236818
DOI
10.1016/j.jpba.2018.07.040
PII: S0731-7085(18)31472-9
Knihovny.cz E-zdroje
- Klíčová slova
- Amlodipine, Degradation impurity, Drug−excipient interactions, Structural elucidation, UHPLC–MS,
- MeSH
- amlodipin chemie MeSH
- časové faktory MeSH
- chromatografie s reverzní fází MeSH
- farmaceutická chemie metody MeSH
- fixní kombinace léků MeSH
- formaldehyd chemie MeSH
- hmotnostní spektrometrie s elektrosprejovou ionizací MeSH
- hydrochlorthiazid chemie MeSH
- kontaminace léku * MeSH
- magnetická rezonanční spektroskopie MeSH
- molekulární struktura MeSH
- pomocné látky chemie MeSH
- stabilita léku MeSH
- valsartan chemie MeSH
- vysokoúčinná kapalinová chromatografie MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- amlodipin MeSH
- fixní kombinace léků MeSH
- formaldehyd MeSH
- hydrochlorthiazid MeSH
- pomocné látky MeSH
- valsartan MeSH
New unknown impurity at m/z 421.15 was observed during the accelerated stability analysis (40 °C/75% relative humidity) in the multi-component tablets of amlodipine besylate by reversed-phase ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS). UHPLC-MS and nuclear magnetic resonance (NMR) techniques were employed to identify and fully characterize the degradation compound. The degradation product was unambiguously identified as 3-ethyl 5-methyl 4-(2-chlorophenyl)-6-methyl-2-(morpholin-2-yl)-1,4-dihydropyridine-3,5-dicarboxylate and mechanism of its formation was proposed. It was confirmed that the degradation product was formed by the reaction of amlodipine with formaldehyde originating from the excipients present in the dosage form.
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