RP HPLC Method Development & Validation for Vadadustat in Bulk Drug and Pharmaceutical Dosage Forms
Authors: Yenni Parimala, KEV NAGOJI, B. Kiran Kumar, Ragolu Swetha, Mendi Tarun
Keywords: Vadadustat, RP-HPLC, Method Development, Validation, Stability-Indicating Assay, ICH Q2 (R1).
Abstract:
A rapid, precise, and stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the quantitative estimation of Vadadustat in bulk and pharmaceutical dosage forms. Chromatographic separation was achieved on an Agilent Eclipse XDB C18 column (150 × 4.6 mm, 3.5 μm) using an isocratic mobile phase of acetonitrile and 0.1% triethylamine buffer (pH 2.5, adjusted with orthophosphoric acid) in the ratio of 30:70 v/v at a flow rate of 1.0 mL/min. Detection was carried out at 234 nm using a PDA detector. The retention time of Vadadustat was 2.563 min with sharp, symmetric peaks and satisfactory system suitability parameters (tailing factor 1.15, theoretical plates >2000). The method was validated as per ICH Q2 (R1) guidelines for specificity, linearity, accuracy, precision, robustness, sensitivity, and stability-indicating capacity. Linearity was observed in the concentration range of 37.5–225 µg/mL (R² = 0.9998). The percentage recovery ranged between 99.4–101.1%, confirming accuracy. Precision studies showed %RSD values <2.0, establishing method reproducibility. The LOD and LOQ were 0.45 µg/mL and 1.50 µg/mL, respectively. Forced degradation studies under hydrolytic, oxidative, photolytic, reductive, and thermal conditions demonstrated the stability-indicating nature of the method. The developed RP-HPLC method is simple, reliable, and suitable for routine quality control analysis of Vadadustat in bulk and pharmaceutical formulations.
