Spectrophotometric determination of ezetimibe in pharmaceutical formulations

Abstract

Ezetimibe is chemically 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S),hydroxypropyl )-4(S)-(4-hydroxyphenyl)-2-azetidinone. It is a selective cholesterol absorption inhibitor. A simple, sensitive, accurate, rapid and economical spectrophotometric method is developed, which is based on the formation of blue coloured chromogen, when the drug reacts with Folin-Ciocalteu (FC) reagent in alkaline medium. The colored species has an absorption maximum at 760 nm and obey Beer's law in the concentration range 4-22 μg μL -1 . The proposed method was tested on the pharmaceutical formulations. The reproducibility, repeatability and precision of method are very good as shown by the low values of standard deviation, standard error of mean, coefficient of variation and % range of error (within 95% confidence limits). The proposed method can be successfully employed for the routine analysis of ezetimibe in tablet dosage forms.