STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF ZOLEDRONIC ACID IN INJECTABLES BY RP –HPLC

The objective of present work is to develop a stability indicating high performance liquid chromatographic (HPLC) assay method for Zoledronic acid. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. In other stress conditions also the drug was found to be stable. Successful separation of the drug under stress conditions was achieved on a Zorbax c8(250 x 4.6), 5 µm column using a mixture of 10 mM solution of Potassium dihydrogen orthophosphate (pH-3.2) methanol (95:5) as mobile phase. The flow rate was 0.7 mL/min and the analysis was performed using UV-Visible detector at 210 nm. The developed HPLC method is to assay the determination of Zoledronic acid and to determine related substances. It can be used to evaluate the quality of regular production samples.