HPLC Estimation of New Impurity Methyl Ezetimibe in Ezetimibe Drug
A new gradient elution mode HPLC method was developed and validated to detect and monitor the novel impurity namely methyl ezitimibe in ezetimibe drug substances. Chromatographic detection and analysis of methyl ezetimibe was performed on XBridge C18 column with mobile phase consisting of 0.02 M phosphate buffer (pH 5) and acetonitrile with 1 mL/min flow rate in gradient elution mode. Methyl ezetimibe was detected and monitored at 248 nm. The calibration curve was linear over range of 0.015 to 0.219% concentration. The limit of detection and quantification were computed as 0.005% (signal to noise ratio 3.60) and 0.015% (signal to noise ratio 15.96), respectively. The precision was 0.97% (%RSD) and accuracy was 93.2 to 98.2% (recovery). The developed method was proved suitable to detect and monitor methyl ezetimibe impurity in ezetimibe drug substances.