A Comparative Study for Method Development and Validation of Daprodustat in Bulk and Pharmaceutical Tablet Dosage Form by UV-visible and RP-HPLC.

This research introduces a straightforward, rapid, sensitive, and selective analytical method for measuring daprodustat in both bulk powder and tablet forms. The techniques used include UV-Visible spectrophotometry and reversed-phase high-performance liquid chromatography (RP-HPLC). For the UV-Visible method, a Systonic AU-2702 double-beam spectrophotometer was used to measure Daprodustat 's absorbance at 265 nm. The RP-HPLC procedure employed a Shimadzu SPD-10A C18 column (250×4.6 mm, 5 µm). The mobile phase consisted of a mixture of acetonitrile and distilled water (70:30, v/v), with 0.1% formic acid added. Key operational parameters included a flow rate of 1.2 mL/min, an injection volume of 10 μL, and a column temperature of 30 °C. The method's linearity ranged from 10 to 100 μg/mL. The entire procedure was validated following ICH Q2 (R1) guidelines, confirming its specificity, linearity, sensitivity, precision, accuracy, robustness, and system suitability. The technique yields highly sensitive results, with Limits of Detection (LODs) and Limit of Quantification (LOQs) of 0.6174 μg/mL and 1.87μg/mL for daprodustat. Recovery rates ranged from 98% to 102%, and both intra-day and inter-day precision (measured by % RSD) were below 2%. The method demonstrated excellent specificity, avoiding interference from excipients or formulation matrices. Overall, this study provides a complete analytical framework applicable for routine pharmaceutical analysis, ensuring quality control, safety assessment, and regulatory compliance for daprodustat.