METHOD DEVELOPMENT AND VALIDATION FOR THE ASSAY OF ZOLEDRONIC ACID IN PHARMACEUTICAL DOSAGE FORM USING HIGH PERFORMANCE LIQUID CHROMATOGRAPHY TECHNIQUE
Zoledronic acid is an imidazole derivative, chemically it is [1-hydroxy-2-(1H-imidazol-1-yl) ethane-1,1- diyl]bis(phosphonic acid). It was white crystalline powder soluble in NaOH & sparingly soluble in water while it was insoluble in organic solvents. It was used as bone resorption inhibitor in malignant hypocalcaemia. The method guidelines to optimize the parameters for the assay have been analyzed. An Isocratic, Reversed Phase Liquid Chromatographic method was developed for the quantitative determination of zoledronicacid. The chromatographic separation was achieved on Hypersil BDS C18 column (250×4.6mm) using Orthophosphoric acid having pH of about 3.2. Hence from the above results obtained, it can be inferred that the developed method was validated with respect to linearity, precision, robustness proving the stability indicating power of the method