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Abstract

TREATMENT OF SUPERFACIAL MYCOSES RESEARCHEBERCANOZOLE /EBERNET

*Ghodke Krushna Somnath and Kale Shital Rajendra

Abstract

In vitro and preclinical studies have demonstrated better therapeutic efficacy with eberconazole than clotrimazole and ketoconazole. The objective of current investigation was to study the degradation behaviour of eberconazole nitrate and mometasone furoate under different International Conference on harmonisation recommended stress condition using reverse phase high performance liquid chromatographic method and to establish validated stability-indicating high performance liquid chromatographic method to determine purity of eberconazole nitrate and mometasone furoate in presence of its impurities, forced degradation products and placebo in pharmaceutical dosage forms. Topical application of eberconazole was well tolerated in preclinical studies without any report of delayed hypersensitivity or photosensitivity reactions. There were no phototoxic effects. There was no significant systemic absorption. Animal toxicity studies have shown that it is safe, and the No Observed Effect Level was 2 ml/kg body weight in tested animals. It was not mutagenic and shared similar cytotoxicity profile with other imidazole antifungal products studied The method was developed using Hypersil BDS, C18, 150×4.6 mm, 5 μ as stationary phase with mobile phase containing a gradient mixture of solvent A and B. 0.01 M phosphate buffer with 0.1% triethyl amine, adjusted pH 7.0 with phosphoric acid was used as buffer. Buffer pH 7.0 was used as solvent A and methanol: acetonitrile in 150:850 v/v ratios were used as solvent B. The eluted compounds were monitored at 240 nm. The run time was 50 min. The developed method was validated as per international conference on harmonization guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness.

Keywords: Cream formulation, ointment, lotion, eberconazole nitrate, mometasone furoate, related substances, validated, antifungal. antisacbies.


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