STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF VADADUSTAT BY USING HPLC IN BULK AND PHARMACEUTICAL DOSAGE FORM.
Abstract
A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Vadadustat in bulk and pharmaceutical dosage form. Chromatographic separation of Vadadustat was achieved on Waters Alliance-e2695, by using Waters Luna Phenyl Hexyl (150x4.6mm, 3.5µm) column and the mobile phase containing Acetonitrile and 0.1% TFA in the ratio of 40:60% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 257nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Vadadustat were NLT 2000 and should not be more than 2, respectively. % Relative standard deviation of peak areas of all measurements is always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be a simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Vadadustat.
Keywords:
Vadadustat, RP-HPLC, Method Development, Method Validation, Quantitative Analysis, Pharmaceutical Dosage FormDOI
https://doi.org/10.37022/wjcmpr.v8i1.380References
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