Analytical Method Development and Validation of Vadadustat in Bulk and Pharmaceutical Dosage Forms by Using RP-HPLC

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 pharmaceutical dosage form. Chromatographic separation of Vadadustat was achieved on Waters Alliance-e2695, by using Inertsil ODS, 150×4.6mm, 3.5μ column and the mobile phase containing Acetonitrile and 0.1% Formic acid in the ratio of 20:80% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 234nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Vadadustat were NLT 2000 and should not more than 2 respectively. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate and robust method for quantitative analysis of Vadadustat.