Development and validation of a stability-indicating micellar electrokinetic chromatography method for the determination of ezetimibe in pharmaceutical formulations.
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.
Dalmora
Sérgio L
SL
Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria, Brazil. sdalmora@terra.com.br
Oliveira
Paulo R
PR
Barth
Thiago
T
Todeschini
Vítor
V
D000924:Anticholesteremic Agents / Q000032:analysis*; D001384:Azetidines / Q000032:analysis*; D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D000069438:Ezetimibe; D004364:Pharmaceutical Preparations / Q000032:analysis*
D000924:Anticholesteremic Agents; D001384:Azetidines; D004364:Pharmaceutical Preparations; D000069438:Ezetimibe