ABSTRACT:
Desidustat, a hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, has gained significant attention as an effective therapeutic agent for managing anemia associated with chronic kidney disease (CKD). With its growing clinical application, the development of robust and reliable analytical methods is crucial for ensuring its quality safety, and regulatory compliance. Among t of this technologyhe available techniques, Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) is widely recognized as the most preferred method for the quantitative estimation of Desidustat due to its superior sensitivity, accuracy, precision, and reproducibility. This review systematically compiles and evaluates the reported analytical methods for the determination of Desidustat in bulk drug and pharmaceutical dosage forms. Emphasis is placed on critical chromatographic parameters, including the choice of stationary phase, mobile phase composition, flow rate, detection wavelength, and retention behavior. Additionally, the review highlights method validation requirements in accordance with International Council for Harmonisation (ICH) guidelines, covering essential parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ). Furthermore, stability-indicating methods involving forced degradation studies under various stress conditions, including acidic, alkaline, oxidative, thermal, and photolytic environments, are discussed to assess the degradation profile of Desidustat. These studies are vital for ensuring drug stability and efficacy throughout its shelf life. Overall, this review provides a comprehensive reference for researchers engaged in pharmaceutical analysis and method development of Desidustat.