Application of Hydrotropic Solubilization Phenomenon for Estimation of Fenticonazole in Bulk and Vaginal capsules using UV-spectrophotometry Methods

Abstract

The purpose of this study is to establish Novel Zero-order UV-Spectrophotometric - absorbance and Zero Order- Area under curve (AUC) methods for estimation of Fenticonazole Nitrate in bulk and vaginal capsules with the application of hydrotropic solubilization phenomenon. Fenticonazole Nitrate is an antifungal drug and it is completely insoluble in water. Pluronic F127 (10% w/v) solution was used as solvent for solubilization of Fenticonazole Nitrate. Maximum absorption for Fenticonazole Nitrate was found to be at wavelength 253nm when dissolved in Pluronic F127 (10% w/v) solution. The methods are based upon measurement of absorbance at 253nm and integration of area under curve for analysis of Fenticonazole Nitrate in the wavelength range of 242.2-261.6nm. The drug followed linearity in the concentration range of 8 - 40µg/mL with correlation coefficient value r2> 0.99 for both methods. The proposed methods were validated for accuracy (% recovery), precision, repeatability and ruggedness, as per ICH guidelines. The proposed methods were applied for qualitative and quantitative estimation of Fenticonazole Nitrate in vaginal capsules and results were found in good agreement with the label claimed. Developed methods can be used for routine analysis of Fenticonazole Nitrate in bulk and Vaginal Capsules.