Development and Optimization of a Capillary Zone Electrophoresis Technique for Simultaneous Determination of Miconazole Nitrate and Hydrocortisone Acetate in a Cream Pharmaceutical Formulation

A simple, fast, inexpensive, and reliable capillary zone electrophoresis (CZE) method for the determination of a mixture of miconazole nitrate (MCZ) and hydrocortisone acetate (HCZ) in a cream formulation has been developed and validated. Optimum conditions were sodium dihydrogen phosphate buffer (5...

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Bibliographic Details
Published in:Journal of AOAC International 2013-11, Vol.96 (6), p.1295-1301
Main Authors: KORANY, Mohamed A, MAHER, Hadir M, GALAL, Shereen M, RAGAB, Marwa A. A
Format: Article
Language:English
Subjects:
Biological and medical sciences
Buffers
Chemistry, Pharmaceutical - methods
Chromatography, High Pressure Liquid
Corticosteroids
Electrophoresis
Electrophoresis, Capillary - methods
Fundamental and applied biological sciences. Psychology
Hydrocortisone - analogs & derivatives
Hydrocortisone - analysis
Hydrogen-Ion Concentration
Methods
Miconazole
Miconazole - analysis
Ointments
Pharmaceutical Preparations - analysis
Phosphates
Phosphates - chemistry
Reproducibility of Results
Solvents - chemistry
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Summary:A simple, fast, inexpensive, and reliable capillary zone electrophoresis (CZE) method for the determination of a mixture of miconazole nitrate (MCZ) and hydrocortisone acetate (HCZ) in a cream formulation has been developed and validated. Optimum conditions were sodium dihydrogen phosphate buffer (50 mM, pH 4) and 30 kV applied voltage in a 85 cm x 75 pm id capillary. Direct UV detection at 230 nm led to adequate sensitivity without interference from the sample excipients. MCZ and HCZ migrated in approximately 165 and 415 s, respectively. The analytical curves had a coefficient of correlation, r, of 0.9999 and 0.9996 for MCZ and HCZ, respectively. The LOD and LOQ were 0.28 and 0.93 microg/mL for MCZ and 0.38 and 1.27 microg/mL for HCZ, respectively. Thus, excellent accuracy and precision were obtained. Recoveries varied from 98 to 102%, and intraday and interday precision, calculated as the RSD, were less than 2.0% for each drug. The proposed CZE method displayed advantageous performance characteristics and can be considered suitable for QC of the MCZ and HCZ cream formulation.
ISSN:1060-3271
1944-7922
DOI:10.5740/jaoacint.11-343