Determination of Zoledronic Acid and Four Common Anions in Zoledronic Acid Injection by Gradient Ion Chromatography with a Self-Regeneration Suppressor

摘要

A simple method to determine zoledronic acid and impurities in drug by ion chromatography with conductivity detection was developed. Target analytes have been sufficiently separated from each other on an Ionpac AS19 by using potassium hydroxide as eluent with a self-regeneration suppressor. This novel proposed method enables direct analysis of zoledronic acid in injection sample and provides good resolution. This novel method also exhibits satisfactory precision (less than 1.68%) and accuracy (90.0% - 110.0%), good linearity (r~(2) = 0.9993 - 0.9999) and sufficient sensitivity (0.007 - 0.030 μg/mL). It can be easily and conveniently adopted for the routine quality control analysis.