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ABSTRACT
A UV spectrophotometric method was developed and validated for the determination of luliconazole (LZL) in bulk and cream formulation using a solvent composed of methanol: water (80:20) at a pre-determined kmax of 298 nm, it was demonstrated linear in the range of 1.0-10.0 pg/mL, and exhibited good correlation coefficient (r2=0.999) and excellent mean recovery (99.03-100.40 %). This method was successfully applied to the determination of LZL content in five marketed brands with recovery range (97.70-99.60 %) and the promising results obtained according to the label claims. The method was validated statistically and by recovery studies for linearity, precision, repeatability, and reproducibility. The method is also adopted for measurement of equilibrium solubility as per WHO guideline in different organic solvents and water. Method was also utilized for stability of analytical solution or short-term stability at room temperature (TRT) and cold temperature (TCT)upto 72 hours as a part of robustness as per ICH Q2R1.Similarity Factor (Sf) and System Suitability Testing were found to be 1 &2.0 % respectively.
KEYWORD
Luliconazole, UV estimation, equilibrium solubility, stability of analytical solution, sf\Similarity Factor, System Suitability Testing.
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1. INTRODUCTION
Luliconazole iodide (LZL) is a novel, broad-spectrum imidazole ring containing antifungal drug classified as Azoles and responsible for cell wall lysis by inhibiting lanosterol 14a-demethylase an enzyme responsible for synthesis of ergosterol in fungi. [1,2] US FDA approved LZL in the November 2013 for tineapedis and other dermal infections. It Stand in market with trade names Luzu, Lulicon U.S. Patents by Valeant Pharmaceuticals North America LLC. Luzu Cream (1%) indicated for the topical treatment of tinea incognito, tineapedis, tineacruris, and tineacorporis caused by the organisms Trichophyton rubrum, Epidermophyton floccosum and Microsporum gypseum [3-7] and also approved in Japan for the treatment of superficial mycosis, such as dermatophytosis, candidiasis, and pityriasis versicolor. [8,9] The MIC of LZL (MIC90) has been found to be 4 to 1,000-fold lower than the MIC90s reported for antifungals, including terbinafine, bifonazole, lanoconazole [1,10-11] and this is because of LZL is belongs Class-II of the BCS pharmaceutical classification.
Recently a few HPLC assay methods have been reported for the estimating of LZL. Literature survey revealed that some of the analytical methods such as stability-indicating assay for LZL in bulk and cream formulation...