Identification and Validation of Genotoxic Impurity in Ezetimibe by Reverse Phase High-Performance Liquid Chromatography

The method emphasizes identification and validation of potential Genotoxic impurity in pharmaceutical drug substances Ezetimibe by Reverse Phase High-Performance Liquid Chromatography (HPLC). was separated using the Zorbax Rx Octylsilane (C8) HPLC column with 250 cm length internal diameter 4.6 mm pore size 5 μm. partition operated at a significant pH 3.0 maintained buffer 10% potassium dihydrogen phosphate Acetonitrile 80:20 ratio mobile phase is gradient inflow 1.5 mL/min. UV absorption maximum were observed 258 nm. proposed approach shows results linear boundaries between 0.16 μg/g to 7.5 correlation coefficient lower than 0.999. further evident accuracy are region 98.82% to101.04% for (5R, 6S)-1-(4-fluorophenyl)-5-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-3-(2-hydroxy-1-phenylethyl)-6-(4hydroxyphenyl)di-hydropyrimidine-2,4(1H,3H)-dione. shown acceptable as per International Council Harmonisation (ICH) guidelines even concentrations.