A NEW ANALYTICAL METHOD FOR ESTIMATION OF ZOLEDRONIC ACID IN COMMERCIAL PHARMACEUTICAL INJECTIONS BY ION-EXCHANGE (IEC) HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

摘要

A new ion exchange high performance liquid chromatographic (IEC). method has been developed and validated for quantitative determination of Zoledronic acid in pharmaceutical injection dosage form. Complete separation was achieved for the parent compound Zoledronic acid, the impurities and extipients in an overall analytical run time of approximately 20 minutes. The proposed chromatographic conditions employed an isocratic elution of mobile phase at constant eluent flow rate of 0.7 mL min~-1 and by using a new generation Allsep~R union exchange column. A UV-Vis detector set at 215 nm was used to monitor the eluate. The 100% aqueous mobile phase consisted of only diluted formic acid without any ion-pair substance. The drug product was subjected to oxidation, hydrolysis, photo-stability, and heat to apply the stress conditions. The method was found to be linear over the concentrations range from 0.200 to 1.200 mgmL-1(25% to 150% of Zoledronic acid concentration). The newly developed method has the requisite accuracy, selectivity and precision to assay Zoledronic acid in commercial pharmaceutical injection dosage form.