Summary
Good agreement between the impurity levels in a batch of a related impurity of ranitidine were obtained by CE and HPLC. A solution of the impurity was positioned on the CE autosampler and analysed sequentially. The extent of degradation was monitored by loss of main peak and the formation of two principal degradation products. It was found that after 9.25 hours only 2% area/area of the original impurity remained. Buffering of the sample solution to pH 7 was shown to minimise this degradation.
Unattended in-situ stability testing of an solution of the impurity in water was performed by CE.
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Altria, K.D., Connolly, P.C. On-line solution stability determination of pharmaceuticals by capillary electrophoresis. Chromatographia 37, 176–178 (1993). https://doi.org/10.1007/BF02275857
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DOI: https://doi.org/10.1007/BF02275857