Method Development and Method Validation of Daprodustat - Using Reverse phase High Performance Liquid Chromatography Method

Aim: Daprodustat in pharmaceutical dosage forms has been previously analyzed quantitatively using reverse-phase high-performance liquid chromatography (RP-HPLC) approach that was easy to use, quick, accurate, sensitive, and repeatable. Materials and methods: Daprodustat was separated chromatographically using a Waters Alliance e2695 system and a Waters X-Terra RP-18 column (150x4.6mm, 3.5µ). The mobile phase was made up of 50% v/v ACN and HSA pH-2.5/OPA. Photodiode array detector was operated at room temperature is utilized to detect absorption at 235 nanometers while the flowrate was fixed at 1.0 ml/minute. Results: For Daprodustat, it was guaranteed that the theoretical plate count and tailing factor would be at least 2000 and 2, respectively. The percentage of standard deviation for peak regions consistently below 2.0 in all measurements. Conclusion: The proposed approach was validated in compliance with ICH requirements, and it was found to be an easy-to-use, reasonably priced, appropriate, precise, accurate, and reliable tool for Daprodustat quantitative evaluation.