Stability-Indicating RP-HPLC Method for the Quantification of Daprodusdat in Pharmaceutical Formulation

This study describes a simple, rapid, sensitive and selective RP-HPLC method for the quantification of daprodustat in bulk and tablet dosage forms. In the study, the stationary phase consisted of a Zorbax SB-C18 (150 mm x 4.6 mm, 5 mu m particle size) column, and the mobile phase consisted of a mixture of acetonitrile:distilled water (80:20, v/v) containing 0.1% formic acid. The flow rate was 1.2 mL min-1, the injection volume was 10 mu L and the column temperature was set at 30 degrees C. The linearity range of the method was 10-150 mu g mL-1 and acceptable precision and accuracy values were obtained for the values in this range. After the developed method was validated according to ICH Q2 (R1) guideline, it was successfully applied to bulk and tablet dosage form preparations of daprodustat. The method has also been successfully applied to forced degradation studies with exposure to various stress conditions, including acid, base, oxidative stress and thermal degradation following ICH Q1B guidelines.