Abstract :
Vadadustat was quantitatively estimated in bulk and dose forms using a quick, stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method that was developed and validated. With a flow rate of 1.0 mL/min, an isocratic mobile phase consisting of acetonitrile and 0.1% triethylamine buffer (pH 2.5) (30:70 v/v), and UV detection at 234 nm, the best separation was accomplished on an Agilent Eclipse XDB C18 column. A 2.563-minute retention time was displayed by Vadadustat. ICH-recommended validation of the method showed strong precision, high accuracy (99.4–101.1% recovery), and excellent linearity (R 2 = 0.9998 in the range of 37.5?225 ?g/mL). Studies on forced deterioration validated the stability-indicating character of the approach. Vadadustat quality control can be done easily, reliably, and with the established RP-HPLC method.
Keyword :
Vadadustat, RP-HPLC, Method Development, Validation, Stability-Indicating Assay, ICH Q2 (R1)