+44 1625708989Derivative, derivative of the ratio spectrophotometric and stability-indicating RP-HPLC methods for the determination of mometasone furoate and miconazole nitrate in cream
Author(s): Ramzia I. El-Bagary, Marwa A. Fouad, Manal A. El-Shaal and Enas H. TolbaThree simple, selective and precise methods, namely, derivative, derivative of the ratio spectrophotometric and high performance liquid chromatographic (HPLC) methods were developed and validated for the simultaneous determination of mometasone furoate and miconazole nitrate in mixture. The first method involves the use of derivative spectrophotometry with the zero-crossing technique where mometasone furoate was determined using its 1D (λ= 8) amplitude at 270.5 nm and miconazole nitrate was determined using its 3D (λ= 4) amplitude at 282.1 nm. The second method involves the application of the second derivative of the ratio spectrophotometric method where mometasone furoate and miconazole nitrate were determined using Δλ= 4 at 267.2 nm and 281.2 nm, respectively. The third method is based on gradient elution of mometasone furoate and its alkaline degradation products along with miconazole nitrate on reversed phase C18 column, (3.9 × 300 mm, 10μm) - Waters , using a mobile phase consisting of 1.5% w/v aqueous ammonium acetate buffer, pH 7.6 and acetonitrile, at a flow rate of 2 mL/min. Quantitation was achieved applying dual wavelength detection where mometasone furoate and its alkaline degradation products were detected at 240 nm and miconazole nitrate was detected at 230 nm at ambient temperature. In addition, products from alkaline degradation of mometasone furoate were verified by LC-MS. The methods were validated according to the International Conference on Harmonization (ICH) guidelines. The selectivity of the proposed methods was tested using laboratory-prepared mixtures. The developed methods were successfully applied for the determination of mometasone furoate and miconazole nitrate in bulk and in its pharmaceutical preparation.
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