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Drug-excipient compatibility testing-Identification and characterization of degradation products of phenylephrine in several pharmaceutical formulations against the common cold
M. Douša, P. Gibala, J. Havlíček, L. Plaček, M. Tkadlecová, J. Břicháč,
Language English Country England, Great Britain
Document type Journal Article
- MeSH
- Models, Chemical MeSH
- Chemistry Techniques, Analytical MeSH
- Chromatography, Liquid methods MeSH
- Chemistry, Pharmaceutical methods MeSH
- Phenylephrine analysis chemistry MeSH
- Mass Spectrometry methods MeSH
- Drug Contamination MeSH
- Pharmaceutical Preparations analysis MeSH
- Magnetic Resonance Spectroscopy methods MeSH
- Excipients chemistry MeSH
- Sucrose analysis MeSH
- Drug Stability MeSH
- Chromatography, High Pressure Liquid methods MeSH
- Publication type
- Journal Article 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.
References provided by Crossref.org
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