Eco-Friendly UV Spectroscopic Method for Precise Quantification of Daprodustat in Pharmaceuticals
摘要
Daprodustat is a new hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) and a novel medication for treating chronic kidney disease anaemia. Daprodustat boosts endogenous erythropoietin production, regulates iron metabolism, and is an alternative erythropoiesis-stimulating agent. The aim of this study is to develop and validate a simple, accurate, and environmentally friendly ultraviolet (UV) spectroscopic method for the quantitative analysis of daprodustat in pharmaceutical formulations. The UV spectrophotometric method was prepared using methanol as the solvent and validated according to the International Council for Harmonisation (ICH) Q2 (R2) guidelines. The process was tested for linearity, precision, accuracy, robustness, limit of detection (LOD), and quantification (LOQ). Daprodustat showed maximum absorbance λmax = 261.45 nm in methanol. The linearity range was 4–16 μg/mL, with a regression equation of y = 0.0577x + 0.0477 and a correlation coefficient R2 = 0.9983. The procedure demonstrated excellent precision (relative standard deviation (%RSD) < 2%) and recovery at 98–99%. The LOD and LOQ were 0.672 μg/mL and 2.0 μg/mL, respectively. The new UV spectrophotometric method for quantifying daprodustat in solid dispersions proved simple, accurate, and precise. Environmental sustainability was assessed using Analytical GREEness (AGREE) and the Green Analytical Procedure Index (GAPI). Accordingly, this validated UV spectroscopic method can be effectively used for routine quality control analysis of daprodustat in solid dispersions, providing a cost-effective and sustainable approach to analytical evaluation.