Determination of hydroxypropyl-beta-cyclodextrin in plasma and urine by size-exclusion chromatography with post-column complexation.

The analytical method described here provides the appropriate sensitivity and selectivity for the determination of unlabelled hydroxypropyl-beta-cyclodextrin as a parenteral carrier in pharmaceutical formulations. The method may also be used in clinical trials evaluating the fate and pharmacokinetic profile of this compound, which was isolated from the biological matrix by solid-phase extraction with Bond Elut C18 cartridges. The lack of uniformity of the product was circumvented by the use of a size-exclusion chromatographic column. An indirect colorimetric complexation method was used for detection. The detection limit was 0.1 micrograms per 2 ml of biological fluid and the extraction recovery was sufficient (78%).