High-Performance Liquid Chromatographic Separation of 3-(Cyclopentylhydroxyphenylacetyl)oxy-1,1-dimethyl-pyrrolidinium Bromide Diastereomers

摘要

Retention of glycopyrrolate and its diastereomeric impurity was studied on a β-cyclodextrin-bonded phase column as function of pH and salt additives. The retention can be modeled by a linear model with pH and ionic strength as independent variables. On the basis of these data, simple and precise method for diastereomeric purity determination of glycopyrrolate was developed.