Analysis of Sugar Alcohol Excipients in Pharmaceutical Tablet Formulations

Introduction

Rezex ion exclusion HPLC columns are the solution for several published USP methodologies. The Rezex RPM (Pb+2) and RCM/ RCU (Ca+2) phases will give you the selectivity needed while the short Rezex RPM 100 x 7.8 mm columns will help to increase throughput.

Tablet formulations of most major pharmaceutical drug products contain significant amounts of inactive ingredients (excipients) in their formulations. Such excipients are often used as binders to hold a tablet together or as a filler to increase the bulk volume of a tablet (especially for highly potent active pharmaceutical ingre- dients). Sugar alcohols, such as mannitol, sorbitol, and xylitol, are often used as fillers because of their inert properties and sweet taste1.

While inexpensive and convenient, such sugar alcohols require unique methods for analysis and quantitation by HPLC due to their high polarity and lack of a UV absorbing chromophore. For such separations, ion exclusion chromatography is often used to detect and quantitate sugar alcohols. The method uses a combi- nation of separation modes including gel filtration, ion-exchange, and affinity to resolve minor differences between the sugar alco- hols.