Open AccessIdentification of the Organic Volatile Impurities in Ezitamibe using GC-HS Technique
Author(s) -
Durgababu Rapeti,
Kapavarapu Maruthi Venkata Narayanarao,
P. Shyamala,
Rallabhandi Murali Krishna
Publication year - 2021
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.2021.23071
Subject(s) - chemistry , ezetimibe , chromatography , flame ionization detector , gas chromatography , dichloromethane , methanol , ethyl acetate , acetone , toluene , solvent , tetrahydrofuran , hexane , isopropyl alcohol , diethyl ether , analytical chemistry (journal) , organic chemistry , biochemistry , statin
Ezetimibe prevents intestinal cholesterol synthesis, which in turn reduces the quantity of cholesteroland thereby helps to reduce heart problems and strokes. In the production of ezetimibe, several organicchemical solvents such as methanol, acetone, isopropyl alcohol, dichloromethane, n-hexane, ethylacetate, tetrahydrofuran, toluene and dimethyl formamide were used. The measurement of residualsolvents is necessary for release checks of all drug substances, based on sound manufacturing processes.The analysis of above mentioned nine solvents in ezetimibe drug was investigated using gaschromatographic method employing detection with flame ionization mode. All analyses were performedusing ZB-624 column (30 m length × 0.53 mm identification, 3.0 μm thickness film). The columnoven temperature flux was managed to maintain for 11 min at 40 ºC and then continued to upsurge toa temperature close of 240 ºC at a rate of 20 ºC/min and retained for 4 min. The flame ionizationdetector and injector port were managed at 260 and 200 ºC, respectively. Results after the validation ofthe gas chromatographic method showed the satisfactory linearity, sensitivity, robustness, accuracy,selectivity and precision for the tested organic solvents. This gas chromatographic approach can thereforebe exploited in the assessment of studied nine residual chemical solvents for periodic analysis by gaschromatography for samples of ezetimibe drug.