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ISSN 2063-5346
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Development and Validation for the Identification 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.sa1.129

Abstract

A novel isocratic reverse-phase high-performance liquid chromatographic method for the estimation of Zoledronic acid in parenteral dosage form has been developed. This method is simple, rapid, selective, precise, and accurate. Inert Sustain Swift C18 (250 x 4.6 mm,5μ) column was used, and the separation was accomplished with a mobile phase of pH 2.80 triethylamine buffer and methanol (96:40 volume/volume). A constant 0.8 mL/min was recorded. The 220nm UV detector was used to detect zoledronic acid. Run time is 35 minutes at column temperatures of 30°C and sample temperatures of room temperature with an injection volume of 20μL. It was found that 5.37 min was the retention time of zoledronic acid. Validation of the procedure was performed in accordance with ICH standards. Accuracy, reproducibility, and consistency were all observed using the proposed procedure.

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