Abstract

“DEVELOPMENT AND VALIDATION OF NOVEL UV SPECTROSCOPIC ASSAY METHOD OF EZETIMIBE IN BULK DRUGS AND DRUG FORMULATIONS”

Avinash M. Bhagwat*, Anand P. Khadke, Anuradha M. Patil, Sanjana N. Sawakhande, Rucha J. Kulkarni and Snehal V. Tarade

Abstract

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 ezetimibeanalyte UV-Detector was used at the wavelength 230 nm. The average retention time of ezetimibe was 3.30 min. 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.

Keywords: Develop, Validation, RP-HPLC, Ezetimibe.