Stability Indicating RP-HPLC Method for the Determination of Luliconazole in Pharmaceutical Formulation (Gel)

Abstract

Luliconazole is a wide spectrum antifungal agent and is very potent against dermatophytes with a unique structure, as the imidazole moiety is incorporated into the ketene dithioacetate structure. Luliconazole is the R-enantiomer, and has been found to be more potent than its racemic mixture, Lanoconazole.  A simple, accurate, specific, precise, robust, rapid and selective stability indicating high performance liquid chromatography (HPLC) method was developed for the assay of Luliconazole in bulk and gel based formulation. The HPLC separation was achieved on kromasil C18 (100mm × 4.6mm, 5 μm) column using a mobile phase of ACN: water (70:30, v/v) adjusted the pH 3 with 0.1% orthophosphoric acid at a flow rate of 1 mL· min^-1and UV detection at 295 nm. Peak elutes at 6.15 min appropriate. The method was validated for linearity, repeatability, accuracy, precision, robustness, limit of detection and limit of quantification. The accuracy was between 99.2 -99.6%. The highest R.S.D. amongst interday and intraday precision were found to be 0.24 and 0.17 respectively. The assay was linear over the concentration range of 10-50 μg/ml (R²≈0.999). LOD and LOQ were found to be 0.099 and 0.3005 respectively. Stress testing was carried out in presence of acid, base, hydrogen peroxide, heat and light to demonstrate speci?city of the method as per ICH guidelines. The developed method could separate the potential degradation products from the Luliconazole peak. It was concluded that highest degradation occurred in basic condition. This proposed method was suitable and practical for analyzing the content of Luliconazole in pharmaceutical products and could be of bene?t for the prediction shelf life of Luliconazole in gel based formulations.