Open AccessHPLC Estimation of New Impurity Methyl Ezetimibe in Ezetimibe Drug
Author(s) -
Duggirala Parvatha Venkata Vardhani Devi,
Kapavarapu Maruthi Venkata Narayanarao,
P. Shyamala,
Rallabhandi Murali Krishna,
Komali Siva Prasad
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22533
Subject(s) - ezetimibe , chemistry , chromatography , impurity , calibration curve , detection limit , gradient elution , high performance liquid chromatography , acetonitrile , elution , analytical chemistry (journal) , cholesterol , organic chemistry , biochemistry
A new gradient elution mode HPLC method was developed and validated to detect and monitor thenovel impurity namely methyl ezitimibe in ezetimibe drug substances. Chromatographic detection andanalysis of methyl ezetimibe was performed on XBridge C18 column with mobile phase consisting of0.02 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 rangeof 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 was0.97% (%RSD) and accuracy was 93.2 to 98.2% (recovery). The developed method was proved suitableto detect and monitor methyl ezetimibe impurity in ezetimibe drug substances.