Drug-excipient compatibility testing-Identification and characterization of degradation products of phenylephrine in several pharmaceutical formulations against the common cold
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu časopisecké články
PubMed
21481557
DOI
10.1016/j.jpba.2011.03.027
PII: S0731-7085(11)00161-0
Knihovny.cz E-zdroje
- MeSH
- chemické modely MeSH
- chemické techniky analytické MeSH
- chromatografie kapalinová metody MeSH
- farmaceutická chemie metody MeSH
- fenylefrin analýza chemie MeSH
- hmotnostní spektrometrie metody MeSH
- kontaminace léku MeSH
- léčivé přípravky analýza MeSH
- magnetická rezonanční spektroskopie metody MeSH
- pomocné látky chemie MeSH
- sacharosa analýza MeSH
- stabilita léku MeSH
- vysokoúčinná kapalinová chromatografie metody MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- fenylefrin MeSH
- léčivé přípravky MeSH
- pomocné látky MeSH
- sacharosa MeSH
Different pharmaceutical preparations against the common cold containing phenylephrine (PHE) and saccharose were studied. New impurities were discovered in these preparations after exposure using isocratic ion-pair chromatography separation on a C18 column. LC-MS and NMR techniques were employed to identify and to fully characterize these new compounds. The products were identified as 1-[5-(hydroxymethyl)-2-furyl]-2-methyl-1,2,3,4-tetrahydroisochinolin-4,8-diol and 1-[5-(hydroxymethyl)-2-furyl]-2-methyl-1,2,3,4-tetrahydroisochinolin-4,6-diol. Identification of these degradation products allowed to understand and to confirm their formation mechanism. The developed HPLC method separates of all known impurities and impurities originated from PHE as well.
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