DoE Approach: A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Methylparaben, Mometasone furoate and Eberconazole nitrate in Topical Formulations.
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Date
2014-12
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Abstract
A rapid and sensitive stability indicating RP-HPLC method is developed for the simultaneous estimation of
Methylparaben, Mometasone Furoate and Eberconazole Nitrate in topical formulations. Chromatographic
separation was achieved on Waters Xterra C18 (150 × 4.6 mm, 5μm) using a mobile phase constituted of water
and methanol (35:65, v/v) at a flow rate of 1.50 mL/min and column temperature of 30˚C. All three components
were measured with uv detection at 235 nm. Force degradation study was conducted to determine
Methylparaben, Mometasone Furoate and Eberconazole Nitrate in the presence of degradants and excipients
peaks. Developed method was validated for method precision, specificity, linearity, accuracy, robustness and
solution stability as per ICH guidelines. Method is showing linearity in the range of 0.25-188, 0.50-75 and 2.0-
750 μg/mL for Methylparaben, Mometasone Furoate and Eberconazole Nitrate respectively. The method was
proved to be robust by conducting DOE study. The method is suitable for stability studies, routine analysis and
quality control of topical formulations containing these components, either alone or in combination.
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Keywords
Methylparaben, Mometasone furoate, Eberconazole nitrate, Stability indicating, DoE
Citation
Modi Prakashkumar B, Shah Nehal J. DoE Approach: A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Methylparaben, Mometasone furoate and Eberconazole nitrate in Topical Formulations. Journal of Applied Pharmaceutical Science. 2014 Dec; 4(12): 20-25.