ABSTRACT:
Desidustat is an inhibitor of hypoxia-inducible factor-prolyl hydroxylase for the treatment of anemia associated with chronic kidney disease. For the estimation of Desidustat in human plasma, a precise, accurate, and sensitive RP-HPLC method has been developed and validated. The separation was achieved using the isocratic method with an Agilent Zorbax Eclipse C18 column. The separation was performed using a flow rate of 1mL/min and a detection wavelength of 238 nm. The retention time of Desidustat and IS were 3.9 and 6.4 minutes, respectively. The linearity is observed within the concentration range 0.6 – 36 µg/mL, exhibiting a robust correlation coefficient of 0.9999. The validation and stability study were conducted in accordance with the ICH M10 guidelines. The findings from the study suggest that the method may apply to pharmacokinetic, bioequivalence, and therapeutic drug monitoring studies in routine practice.