Development of HPLC Method for the Identification Related Substances and Assay of Zoledronic Acid in a Tablet Dosage Form

A simple method has been developed for the determination of zoledronic acid in its pure form and in parenteral form using Reverse Phase High Performance Liquid Chromatography (RP HPLC). Chromatography was carried out on Allsep anion exchange column (150x4.6mm, 7μ). The mobile phase for identification consisted of 0.2% formic acid solution at a pH 3.0 ± 0.05 and the mobile phase for assay was phosphate buffer and methanol in the ratio of 900:100 v/v. It was pumped through the chromatographic system at a flow rate of 0.7ml/min and identified with refractive index detector. The retention time of zoledronic acid was 7.351 min. The method was validated and found to be reproducible for the analysis of the drug in parenteral preparations. Assay for the parenteral samples was performed using RP HPLC with UV detector and the results were found to be within acceptable limits