Quantification of trace levels of β‐cyclodextrin and substitution patterns in hydroxypropyl‐β‐cyclodextrin using high‐performance liquid chromatography with polarimetric detection

Abstract

Abstract A high‐performance liquid chromatographic (HPLC) method has been developed for separation and determination of components in hydroxypropyl‐β‐cyclodextrin (HP‐β‐CD). The method involves separation on an amino‐bonded HPLC column using water–acetonitrile as a mobile phase with a polarimetric HPLC detector for quantification. It provides good selectivity and sensitivity and can also be used to compare different sources of HP‐β‐CD and to measure batch to batch variation. The similarity of the values of molar optical rotation for β‐cyclodextrin (β‐CD) and HP‐β‐CD suggests that a polarimetric HPLC detector may be used with a straightforward area normalization method, to quantify the proportion of β‐CD in any HP‐β‐CD sample. Trace amounts of β‐CD in HP‐β‐CD have been measured to a precision of 0.01%. © 1993 Wiley‐Liss, Inc.