METHOD VALIDATION FOR ZOLEDRONIC ACID AND ITS RELATED COMPOUNDS IN LARGE AND SMALL VOLUME INJECTIONS BY RP CHROMATOGRAPHY WITH UV DETECTION
Nagaraju Dasari, Sridhar V. S. Juttada and B. S. A. Andrews*
ABSTRACT
A validated, specific, stability indicating reversed-phase liquid chromatographic method has been developed for quantitative analysis of Zoledronic acid and its related substances in liquid injection. The degradation products was achieved on a Phenyl Hexyl (250x4.6mm,5μm) column with a mobile phase constituted of 1-octane sulphonic acid of sodium salt monohydrate, EDTA disodium salt, Perchloricacid and Ortho phosphoric acid, the detection was performed at 215nm.The retention times of Zoledronic acid, Imidazole-1-yl acetic acid and Imidazole standard are in minutes 5.94, 17.10 & 24.71 respectively. The method was linear with the concentration range from 0 to 300% with correlation and regression coefficient are above 0.998 for Zoledronic acid, Imidazole-1-yl acetic acid and Imidazole standard respectively. The method was validated in according to ICH guidelines USP with respect to accuracy, precision, specificity and can be used to determine related impurities and degradation products.
Keywords: RP HPLC, UV&PDA detector, Zoledronic acid, Imidazole standard, Imidazole-1-yl-standard, validation, ICH guideline.
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