HYDROLYTIC DEGRADATION STUDY OF ROXADUSTAT BY RP-HPLC AND HPTLC

Objective: Simple, rapid RP-HPLC and HPTLC methods have been developed in order to study the degradation of Roxadustat under various stress conditions. The Kinetics hydrolytic is studied. Methods: Optimum separation its products was achieved using following conditions HPLC, Agilent eclipse XDB-C8 (150×4.6 mm) column, mobile phase composed methanol: phosphate buffer (pH 5, 0.05 M) (70:30 v/v) with UV detection at 262 nm. flow rate 1.0 ml/min. RT 4.6±0.02 min. work for performed on Aluminium plates precoated silica gel 60 F254, (10 cm × 10 250 μm layer thickness). Toulene: Ethyl Acetate: Glacial acetic acid (5:5:0.5 v/v/v) then scanned. system found give a compact spot (Rf value 0.58±0.02). Results: In HPLC calibration curves plotted were be linear over concentration range 2.5-25μg/ml, correlation coefficient R2=0.9994. 500-2500 ng/band, regression R2=0.9957. analytical performance proposed validated as per ICH Q2 (R1) guidelines. degradant peaks well resolved from peak. Significant observed hydrolysis, alkali oxidative degradation. drug relatively stable towards photolysis, neutral thermal Conclusion: current work, simple determination presence developed. information presented herein could very useful while developing formulation procedures prevent It can used routine quality control test.