Impurity profiling of etimicin sulfate by liquid chromatography ion-trap mass spectrometry
Yao-zuo Yuan1, Mei Zhang, Xia-Lei Fan
1Jiang Su Provincial Institute for Food and Drug Control, Nanjing 210008, China.
Abstract:
A reversed phase (RP)-LC method using a C(18) 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 MS(n) 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.
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