DEVELOP A NEW RP-HPLC METHOD AND VALIDATION FOR QUANTITATIVE DRUG CONTENT DETERMINATION OF EZETIMIBE FROM MARKETED FORMULATED TABLETS

This study has done to develop a cheap, reliable and stable method for the drug content determination of Ezetimibe from its formulated tablets. A binary reversed–phase (C18-Column) high performance liquid chromatograph was used for the analysis. An isocratic method was applied with the mobile phase acetonitrile and water in the ratio of 75:25 (by volume). For detection the Ezetimibe analyte UV-Detector was used at the wave length 230 nm. The average retention time of Ezetimibe was 3.30 minutes. The flow rate was 1.0 mL / min. The method was linear with regression coefficient (R2) 0.994. The limit of detection (LOD) and limit of quantification (LOQ) were calculated 0.04 and 0.12 µg / mL. Average inter-day and intra-day recovery percentage were computed 98.44 % and 99.62 % with coefficient variation percentage 3.07 and 0.75 %. Recovery results were showed good accuracy of the method. Hence, this method validation was statistically significant