Stationary Phase

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.   

In this review articles, the development, formulation, and manufacture of drugs, analytical method development & validation play a critical role. Methods are developed for ensuring purity, identity, potency, and performance of pharmaceutical products. Methods should be applied to the extent that they are sufficient for their intended purpose. Throughout the life cycle of a drug product and substance, a range of activities are associated with developing and validating methods. An objective of method validation is to prove that the procedure can be used as intended. Once the method is developed, validation is performed. Different national and international committees have defined the parameters for method validation. The International Conference on Harmonization attempted to harmonize pharmaceutical applications. In accordance with the ICH, other organizations define Linearity, Selectivity/Specificity, Range, Accuracy, Precision (repeatability, intermediate precision, and reproducibility), Limit of quantitation, Limit of detection, Ruggedness, and Robustness.