Yuan Y.-Z.,Jiang Su Provincial Institute for Food and Drug Control |
Yuan Y.-Z.,Catholic University of Leuven |
Zhang M.,Jiang Su Provincial Institute for Food and Drug Control |
Fan X.-L.,Jiang Su Provincial Institute for Food and Drug Control |
And 6 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2012
A reversed phase (RP)-LC method using a C18 column resistant to basic pH and an alkaline (pH 10) aqueous mobile phase was developed and coupled to MS with an electrospray ionization (ESI) source in the positive ion mode which provides MSn capability. In total, 26 impurities were detected in a commercial sample. The structures of the impurities were proposed based on comparison of their fragmentation patterns with those of the available reference substances, the synthetic route and literature data. Starting material and its residual impurities, intermediates, synthetic by-products and degradation products were the main sources of those impurities. 14 impurities described in this work were newly identified. © 2012 Elsevier B.V. Source