Development and validation of a method for quantitative determination of econazole nitrate in cream formulation by capillary zone electrophoresis.
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.
Gaona-Galdos
Angel Arturo
AA
Faculty of Pharmaceutical Sciences, University of São Paulo, Av. Prof. Lineu Prestes 580, 05508-900 São Paulo, SP, Brazil.
Zanolli Filho
Luiz Antonio
LA
Tavares
Marina Franco Maggi
MF
Aurora-Prado
María Segunda
MS
Santoro
Maria Inês Rocha Miritello
MI
Kedor-Hackmann
Erika Rosa Maria
ER
D000935:Antifungal Agents / Q000032:analysis*; D004464:Econazole / Q000032:analysis*; D019075:Electrophoresis, Capillary; D007202:Indicators and Reagents; D009824:Ointments / Q000032:analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
D000935:Antifungal Agents; D007202:Indicators and Reagents; D009824:Ointments; D012996:Solutions; D004464:Econazole