QUANTIFICATION OF TRACE LEVELS OF BETA-CYCLODEXTRIN AND SUBSTITUTION PATTERNS IN HYDROXYPROPYL-BETA-CYCLODEXTRIN USING HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY WITH POLARIMETRIC DETECTION

A high-performance liquid chromatographic (HPLC) method has been devel oped for separation and determination of components in hydroxypropyl-b eta-cyclodextrin (HP-beta-CD). The method involves separation on an am ino-bonded HPLC column using water-acetonitrile as a mobile phase with a polarimetric HPLC detector for quantification. It provides good sel ectivity and sensitivity and can also be used to compare different sou rces of HP-beta-CD and to measure batch to batch variation. The simila rity of the values of molar optical rotation for beta-cyclodextrin (be ta-CD) and HP-beta-CD suggests that a polarimetric HPLC detector may b e used with a straightforward area normalization method, to quantify t he proportion of beta-CD in any HP-beta-CD sample. Trace amounts of be ta-CD in HP-beta-CD have been measured to a precision of 0.01%. (C) 19 93 Wiley-Liss, Inc.