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

2013 
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 (C 18 - Column) high performance liqui d 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 reten tion time of Ezetimibe was 3.30 min utes . The flow rate was 1.0 mL / min. The method was linear with regression coefficient (R 2 ) 0.994. The limit of detection (LOD) and limit of quantification (LOQ ) were calculated 0.04 and 0.12 µg / mL. Average inter - day a nd 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.
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