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ABSTRACT:
In the current work a UV-Visible spectroscopical technique having simplicity, sensitivity, rapidness, preciseness and accuracy has been developed and validated for quantification of Mometasone Furoate (MF) in bulk and pharmaceutical dosage forms. The guiding principle of the International Conference on Harmonization (ICH), were followed and the method has been validated for various analytical parameters like linearity, precision, and accuracy robustness, ruggedness, LOD, quantification limit and formulation analysis. The obtained results of the study were validated statistically. MF was detected at wavelength maxima of 246 nm in dichloromethane using spectrophotometer (double beam UV-Visible) and analysed in a concentration range from 1.0 to 10.0 pg/ ml. The coefficient of correlation (r2) was observed 0.9993 and found in good agreement by Beer Lambert's law. The preciseness (intra-day and inter-day) was found compliant with the official RCD limits (RSD<2%). The recovery studies were performed to verify the accuracy of the projected methodology. The sensitivity of the strategy was assessed by decisive the limit of detection and limit of quantification. It had been concluded that the projected methodology for estimation of MF in active and in marketed formulation (cream) was easy, accurate, economical and precise. It is utilized with success within the quality control of dosage form and laboratory analysis.
KEYWORDS: Mometasone Furoate, Dichloromethane, UV-Visible spectroscopic method, Beer Lambert's law.
INTRODUCTION:
MF is a corticosteroid (glucocorticoid) having an anti-inflammatory activity. The exact mechanism of MF on allergic rhinitis has not been recognized. Corticosteroids showed a wide range of effects on various cell types such as mast cells, eosinoplills, neutrophills, macrophages, and lymphocytes1'2. The chemical name of MF is (11ß, 16a)-9, 21-dichloro-11hydroxy-16-methyl-3,20-dioxopregna-1,4-dien17-yl 2-furoate. It is white or off-white crystalline powder, soluble in acetone, dichloromethane, and slightly soluble in ethanol. Practically insoluble in water3,4,5. It is official in Indian and British pharmacopoeia.
Literature survey indicate that many analytical methods are reported for determination of MF using HPLC, HPTLC, RP-HPLC, in different solvents but no spectroscopic method was available for estimation of MF in bulk and pharmaceutical dosage form (cream) using dichloromethane as solvent6,7.
MATERIALS AND METHODS:
Reagents and chemicals:
MF with 99.56% purity as at work standard was obtained as gift sample from ZCL CHEMICALS Limited, Ankleshwar, India. Dichloromethane was purchased from Fisher Scientific, Mumbai. Ethanol, acetone and octanol was...