Drug-excipient compatibility testing—Identification and characterization of degradation products of phenylephrine in several pharmaceutical formulations against the common cold

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...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2011-07, Vol.55 (5), p.949-956
Main Authors: Douša, Michal, Gibala, Petr, Havlíček, Jaroslav, Plaček, Lukáš, Tkadlecová, Marcela, Břicháč, Jiří
Format: Article
Language:English
Subjects:
Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Chemistry Techniques, Analytical
Chemistry, Pharmaceutical - methods
Chromatography, High Pressure Liquid - methods
Chromatography, Liquid - methods
common cold
Drug Contamination
drug formulations
Drug Stability
drugs
Excipients - chemistry
Excipients compatibility
Fundamental and applied biological sciences. Psychology
General pharmacology
high performance liquid chromatography
Impurities
ion pair chromatography
Magnetic Resonance Spectroscopy - methods
Mass Spectrometry - methods
Medical sciences
Models, Chemical
nuclear magnetic resonance spectroscopy
Pharmaceutical Preparations - analysis
Pharmacology. Drug treatments
Phenylephrine
Phenylephrine - analysis
Phenylephrine - chemistry
Sucrose - analysis
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Summary: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.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2011.03.027