Research Article | Volume: 4, Issue: 12, December, 2014

DoE Approach: A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Methylparaben, Mometasone furoate and Eberconazole nitrate in Topical Formulations

Prakashkumar B. Modi Nehal J. Shah   

Open Access   

Published:  Dec 29, 2014

DOI: 10.7324/JAPS.2014.41204
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 30ËšC. 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.


Keyword:     Methylparaben Mometasone furoate Eberconazole nitrate Stability indicating DoE.


Citation:

Prakashkumar Modi, Nehal J Shah. DoE Approach: A Stability Indicating RP-HPLC Method for Simultaneous Estimation of Methylparaben, Mometasone furoate and Eberconazole nitrate in Topical Formulations. J App Pharm Sci, 2014; 4 (12): 020-025.

Copyright:The Author(s). This is an open access article distributed under the Creative Commons Attribution Non-Commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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