Drug-excipient compatibility testing-Identification and characterization of degradation products of phenylephrine in several pharmaceutical formulations against the common cold
Language English Country England, Great Britain Media print-electronic
Document type Journal Article
PubMed
21481557
DOI
10.1016/j.jpba.2011.03.027
PII: S0731-7085(11)00161-0
Knihovny.cz E-resources
- 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
- Names of Substances
- Phenylephrine MeSH
- Pharmaceutical Preparations MeSH
- Excipients MeSH
- Sucrose 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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