Selective removal of sulfobutylether-Β-cyclodextrin from a pharmaceutical preparation by anion exchange solid-phase extraction

ANYL 66

Kenley K. Ngim, kngim@theravance.com and Zhengtian Gu, ZGu@theravance.com. Analytical Development, Theravance, Inc, 901 Gateway Blvd., South San Francisco, CA 94080
Sulfobutylether-Β-cyclodextrin (SBECD) and hydroxypropyl-Β-cyclodextrin (HPCD) are used in pharmaceutical formulations to increase the solubility of active pharmaceutical ingredients (API). The presence of SBECD in the drug product can render analysis of such formulations by HPLC difficulty. While a suitable reverse-phase HPLC method exists for the analysis of an API in a formulation containing HPCD, the application of the same HPLC method to SBECD containing samples results in chromatographic failure. The development of an effective solid-phase extraction clean-up procedure, which selectively removes SBECD using quaternary amine sorbent, is presented.
 

General Papers
7:00 PM-9:00 PM, Sunday, 10 September 2006 Moscone Center -- Hall D, Poster

Division of Analytical Chemistry

The 232nd ACS National Meeting, San Francisco, CA, September 10-14, 2006