ONLINE SOLUTION STABILITY DETERMINATION OF PHARMACEUTICALS BY CAPILLARY ELECTROPHORESIS

被引:15
作者
ALTRIA, KD
CONNOLLY, PC
机构
[1] Pharmaceutical Analysis, Glaxo Group Research, Ware, SG12 ODP, Herts, Park Road
关键词
CAPILLARY ELECTROPHORESIS; STABILITY TESTING; RANITIDINE RELATED IMPURITIES;
D O I
10.1007/BF02275857
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
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.
引用
收藏
页码:176 / 178
页数:3
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