Combined use of liquid chromatography with mass spectrometry and nuclear magnetic resonance for the identification of degradation compounds in an erythromycin formulation |
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Authors: | M?Pendela S?Béni E?Haghedooren L?Van den?Bossche B?Noszál A?Van?Schepdael J?Hoogmartens Email author" target="_blank">E?AdamsEmail author |
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Institution: | (1) Laboratory for Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Katholieke Universiteit Leuven, O&N2, PB 923, Herestraat 49, 3000 Leuven, Belgium;(2) Department of Pharmaceutical Chemistry, Semmelweis University, Hőgyes Endre u. 9, 1092 Budapest, Hungary; |
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Abstract: | A commercial erythromycin formulation containing erythromycin A (EA) as the major compound showed the presence of an unknown
degradation compound that was co-eluted with erythromycin E (EE) in the European Pharmacopoeia (Ph. Eur.) liquid chromatographic
(LC) method. The amount of the degradation compound increased with respect to time. To separate this unknown (UNK1), investigation
was performed with different LC methods coupled to ultraviolet detection (LC-UV). With the present Ph. Eur. method, the degradation
compound could not be well separated. However, with the most selective LC-UV method (XTerra method), two more degradation
products (UNK2 and UNK3) were found in the formulation which could not be observed using other methods because of their poor
separation. By combining the results obtained with LC-UV, LC/MS and LC/NMR, the degradation products were identified as pseudoerythromycin
A hemiketal (PsEAHK), erythromycin A enol ether carboxylic acid and erythromycin C enol ether carboxylic acid. PsEAHK is known
to be a base-catalysed degradation product of EA, whereas the other two degradation products were newly identified. |
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