title: Use of capillary electrophoresis in drug quality assessment of synthetic porcine secretin.
abstract: The purity profile 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 efficient 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 influence 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.
authors.affiliation: Department of Central Medical Stores, PO Box 639, Gaborone, Botswana.
authors.forename: Baile A
authors.initials: BA
authors.lastname: Moumakwa
authors.forename: Charlene D
authors.initials: CD
authors.lastname: Crawley
authors.forename: Edward
authors.initials: E
authors.lastname: Purich
authors.forename: Les
authors.initials: L
authors.lastname: Edinboro
authors.forename: H Thomas
authors.initials: HT
authors.lastname: Karnes
mesh_terms: D000818:Animals; D002021:Buffers; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D004355:Drug Stability; D019075:Electrophoresis, Capillary / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D011786:Quality Control; D015203:Reproducibility of Results; D012633:Secretin / Q000031:analogs & derivatives* / Q000032:analysis* / Q000302:isolation & purification; D013552:Swine
chemical_list: D002021:Buffers; D012633:Secretin; C064168:secretin, beta-Asp(3)-; C034421:secretin, Asp(3)-