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A Comprehensive Perspective on Forced Degradation, Stability and Robustness conditions of Zoledronic acid Impurities by HPLC in Zoledronic Acid Injection

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Venkata Krishna Reddy P, Rajput Jamatsingh Darbarsingh
» doi: 10.31838/ecb/2023.12.si6.152


The present study was aimed for forced degradation and establishment of solution stability/Robustness conditions of Zoledronic acid Impurities by reverse phase chromatography in Zoledronic Acid Injection. The separation was achieved by using column Inert Sustain Swift C18 (250 x 4.6 mm,5μ) mobile phase consisted of pH 2.80 triethylamine buffer and methanol in the ratio of (96:4 volume/volume). The flow rate was 0.8mL/min. Zoledronic acid was detected using UV detector at the wavelength of 220nm. Column temperature 30°C and sample temperature ambient and injection volume 20μL, run time 35 minutes. The retention time of Zoledronic acid was noted to be 5.37 min respectively. The method was validated as per ICH guidelines. The proposed method was found to be robust and stable.

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