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Use of capillary electrophoresis in drug quality assessment of synthetic porcine secretin
Author(s) -
Moumakwa Baile A.,
Crawley Charlene D.,
Purich Edward,
Edinboro Les,
Karnes H. Thomas
Publication year - 2005
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.419
Subject(s) - chemistry , capillary electrophoresis , chromatography , secretin , high performance liquid chromatography , aqueous solution , electrophoresis , biochemistry , secretion
The purity prole for porcine secretin attributable to contamination by equilibrium products such as aspartoyl 3 secretin has been shown to be dependent on the pH of the analytical system. Capillary zone electrophoresis (CZE) methods have been developed for the efcient separation of synthetic porcine secretin, its equilibrium products and other impurities in aqueous solutions at both acidic and alkaline pH. These conditions are more representative of those used for the reconstitution and administration of porcine secretin, and good results cannot be achieved using HPLC due to poor peak shape above pH 5.8. The inuence of various CZE operational parameters was systematically examined. The methods were validated for accuracy, precision, linearity, LOD and LOQ. A comparative evaluation of the stability of test solutions was determined using CZE and HPLC over a range of pH values. HPLC and CZE methods produced similar results at low pH. Copyright © 2004 John Wiley & Sons, Ltd.