PMID: 18403842Apr 12, 2008Paper

Development and validation of a stability-indicating micellar electrokinetic chromatography method for the determination of ezetimibe in pharmaceutical formulations

Analytical Sciences : the International Journal of the Japan Society for Analytical Chemistry
Sergio Luiz DalmoraVítor Todeschini

Abstract

A micellar electrokinetic chromatography (MEKC) method was validated for the analysis of ezetimibe. The method was carried out on a fused-silica capillary (50 microm i.d.; effective length, 40 cm). The background electrolyte consisted of a 25 mM borate buffer and 25 mM anionic detergent SDS (pH 9.75)/methanol (90:10, v/v). The capillary temperature was maintained at 35 degrees C, the applied voltage was 30 kV; the injection was performed using a pressure mode at 50 mbar for 5 s, with detection at 232 nm. The method was linear in the range of 2-150 microg/mL (R2=0.9999). The specificity and the stability-indicating capability were proven through degradation studies, which also showed that there was no interference of the excipients. The limits of quantitation and detection were 2 and 0.41 microg/mL, respectively. The method was applied for the analysis of ezetimibe pharmaceutical formulations, and the results were compared to those of the liquid-chromatography method.

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Citations

Nov 28, 2013·Journal of Analytical Methods in Chemistry·Mohammed E A HammoudaSaadia M El-Ashry
Sep 12, 2015·Expert Opinion on Drug Discovery·Tao WangLi-Rong Yang
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