Development and Validation of a Stability-indicating Micellar Electrokinetic Chromatography Method for the Determination of Ezetimibe in Pharmaceutical Formulations
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- DALMORA Sérgio L.
- Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria
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- OLIVEIRA Paulo R.
- Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria
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- BARTH Thiago
- Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria
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- TODESCHINI Vítor
- Department of Industrial Pharmacy, Health Science Centre, Federal University of Santa Maria
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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 µm 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°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 µg/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 µg/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.
Journal
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- Analytical Sciences
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Analytical Sciences 24 (4), 499-503, 2008
The Japan Society for Analytical Chemistry
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Keywords
Details 詳細情報について
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- CRID
- 1390001204256203136
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- NII Article ID
- 10021099660
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- NII Book ID
- AA10500785
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- ISSN
- 13482246
- 09106340
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- NDL BIB ID
- 9452286
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- Text Lang
- en
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- Data Source
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- JaLC
- NDL
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed