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Development and validation of a method for quantitative determination of econazole nitrate in cream formulation by capillary zone electrophoresis.

作者信息

Gaona-Galdos Angel Arturo, Zanolli Filho Luiz Antonio, Tavares Marina Franco Maggi, Aurora-Prado María Segunda, Santoro Maria Inês Rocha Miritello, Kedor-Hackmann Erika Rosa Maria

机构信息

Faculty of Pharmaceutical Sciences, University of São Paulo, Av. Prof. Lineu Prestes 580, 05508-900 São Paulo, SP, Brazil.

出版信息

J Chromatogr A. 2008 May 30;1192(2):301-5. doi: 10.1016/j.chroma.2008.03.070. Epub 2008 Mar 28.

DOI:10.1016/j.chroma.2008.03.070
PMID:18406411
Abstract

A simple, fast, inexpensive and reliable capillary zone electrophoresis (CZE) method for the determination of econazole nitrate in cream formulations has been developed and validated. Optimum conditions comprised a pH 2.5 phosphate buffer at 20 mmol L(-1) concentration, +30 kV applied voltage in a 31.5 cm x 50 microm I.D. capillary. Direct UV detection at 200 nm led to an adequate sensitivity without interference from sample excipients. A single extraction step of the cream sample in hydrochloric acid was performed prior to injection. Imidazole (100 microg mL(-1)) was used as internal standard. Econazole nitrate migrates in approximately 1.2 min. The analytical curve presented a coefficient of correlation of 0.9995. Detection and quantitation limits were 1.85 and 5.62 microg mL(-1), respectively. Excellent accuracy and precision were obtained. Recoveries varied from 98.1 to 102.5% and intra- and inter-day precisions, calculated as relative standard deviation (RSD), were better than 2.0%. The proposed CZE method presented advantageous performance characteristics and it can be considered suitable for the quality control of econazole nitrate cream formulations.

摘要

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