Detection and quantitation of cyclodextrins in pharmaceutical preparations comprising a protein in a solution

摘要

A method for testing for the presence of a cyclodextrin or a cyclodextrin derivative in a solution comprising a protein is disclosed, wherein the method comprises: (a) loading a sample of the solution on a size exclusion chromatography (SEC) column, wherein said sample does not undergo a step of extraction prior to being loaded to said column; (b) separating any cyclodextrin or cyclodextrin derivative that may be present in the sample from said protein by SEC; (c) contacting said cyclodextrin or said cyclodextrin derivative with an agent that forms a detectable inclusion complex with a separated cyclodextrin or cyclodextrin derivative; and (d) detecting a signal from said inclusion complex. The method may further comprise: (e) determining the size of said signal, wherein the size of the signal is indicative of the quantity of the cyclodextrin or the cyclodextrin derivative in the solution.