ABSTRACT

A simple, robust, linear analytical method for quantitation of ezetimibe using HPLC was developed and validated. Prepared sample was eluted at 4.9 min by using ACE C18 (250mm X 4.6mm, 5µm) column. 0.1 % Ortho-phosphoric acid and methanol (as 20:80 v/v ratios) was mobile phase for this study. The flow was kept at1.0 mL/min. The peaks were observed at the wavelength of 232nm. All the validation parameters including accuracy and robustness parameters were evaluated in order to validate the method. As per validation results, the method found linear and precise for5 to 30 µg/mL concentrations, accurate at 50% to 150 % of target concentration (10µg/mL) from 5µg/mL to 15 µg/mL, robust at 10% changes at upper and lower side of Organic composition of mobile phases, ± 2nm changes in wavelength selection of 232nm and ± 0.2 mL/min of selected flow rate i.e. of 1.0 mL/min. Keywords: Analytical Method, HPLC, Validation, Ezetimibe, Mobile Phase
Publication date: 01/07/2022

https://ijbpas.com/pdf/2022/July/MS_IJBPAS_2022_6233.pdf

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https://doi.org/10.31032/IJBPAS/2022/11.7.6233