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Ketoconazole is the active ingredient in an antifungal liquid formulation for topical application. A binary gradient HPLC analysis indicated that ketoconazole in the formulation produced four degradation products at minor levels after storage at room temperature for about 3 years.

Isolation, Purification and Structural Identification of Degradation Products from Ketoconazole in a Liquid Formulation: An HPLC and HPLC-MS/MS Study