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Development and validation of stability indicating RP-HPLC method for quantitative estimation of Zoledronic acid in Zoledronic acid solution for infusion pharmaceutical dosage form

. P.Venkateswara Rao, V.Anuradha, D.Ramachandran and C.V.Nageswara Rao


A new, simple, rapid, selective, precise and accurate isocratic reverse phase high performance liquid chromatography assay method has been developed for estimation of Zoledronic acid in parenteral dosage form. The separation was achieved by using column Symmetry C18 (150 x 4.6 mm, 5µ) mobile phase consisted of pH 3.5 triethylamine buffer and methanol in the ratio of (90:10 volume/volume). The flow rate was 0.5mL/min. Zoledronic acid was detected using UV detector at the wavelength of 220 nm. Column temperature 40°C and sample temperature ambient and injection volume 20µL, run time 10 minutes. The retention time of Zoledronic acid was noted to be 3.8 min respectively. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible and consistent.

Keywords: Zoledronic acid, Liquid chromatography, Forced degradation and Validation.

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