Development and validation of a spectroscopic method for the simultaneous analysis of miconazole nitrate and hydrocortisone acetate in pharmaceutical dosage form

摘要

Purpose: To develop a new analytical method for the quantitative analysis of miconazole nitrate (MCN) and hydrocortisone (HCA) in pharmaceutical creams. Methods: The study was accomplished in three steps. In the first stage, a spectroscopic method was developed for the simultaneous analysis of miconazole (MCN) and hydrocortisone (HCA). For this purpose, serial dilutions of both drugs were prepared using ethanol: water (50:50) as the solvent system. All solutions were analyzed for absorbance spectrophotometrically at 205 and 249 nm for MCN and HCA, respectively. The method was validated for linearity, range, accuracy, precision and robustness. A commercial formulation was also assayed by the proposed method. Results: The absorbance data were linear over a concentration range of 1 to 12 μg/mL for MCN and 1 to 40 μg/mL for HCA, with correlation coefficient of 0.9995 and 0.9984, respectively. Limit of detection (LOD) and of quantification (LOQ) of MCN were 0.49 and 1.49 μg/mL, respectively, and for HCA, 1.50 and 4.57 μg/mL, respectively. The assay results for the commercial formulation were within the limits specified in British Pharmacopoeia. Conclusion: Simultaneous quantification of miconazole (MCN) and hydrocortisone (HCA) by UV spectroscopy provides a simple, reliable and robust method for the characterization of a mixture of the drugs in a dosage form.