Estimation of Luliconazole in Formulation and Biofluid

Luliconazole is a novel topical antifungal imidazole with broad-spectrum and potent antifungal activity used in treatment of superficial mycoses. Superficial mycoses are not fatal, but they constitute a serious problem for patients’quality of life in view of the considerable discomfort and/or cosmetic deformity they cause. These diseases are found worldwide and affect 20 to 25% of the world’s population [1]. Dermatophytosis is the most common infection among the superficial mycoses [28]. Luliconazole is a novel antifungal drug launched in India by Ranbaxy Laboratories Ltd. The compound was originally screened from active compounds related to lanoconazole, a potent antidermatophytic drug. Currently, a 1% cream and a 1% solution of LLCZ are available for the treatment of superficial mycoses such as dermatophytosis, candidiasis, and pityriasis versicolor. Topical LLCZ has been introduced in India (approved in 2010). The compound was originally screened from active compounds related to lanoconazole, a potent antidermatophytic drug. The in vitro antifungal activity of LLCZ against Trichophyton spp. was found to be the highest among existing topical antifungal drugs [9-12]. Literature survey revealed that there are very limited number of analytical methods available for estimation of Luliconazole ,such as a validated stabilityindicating LC method for Luliconazole in bulk and cream formulation[13] ,the analytical methods developed for Luliconazole includes LC-MS/MS method for the determination of the Luliconazole in human toenails [14], RP HPLC Method for Assay and related Substances of Luliconazole in Topical Dosage form [15] UV Spectrophotometric Method For The Estimation of Luliconazole In Marketed Formulation (Lotion) [16]. No HPTLC method was reported for quantitative estimation of Luliconazole. Thus, a simple and rapid high performance thin layer chromatography method has been developed and validated for Luliconazole.