Quantitative estimation of fenticonazole nitrate by zero-order derivative area under curve spectrophotometric methods in bulk and in-capsule dosage form

Abstract

The purpose of this study is to establish Zero-order UV-Spectrophotometric - absorbance and Zero Order- Area under curve (AUC) methods for estimation of Fenticonazole Nitrate in bulk and vaginal capsules. Fenticonazole Nitrate is an antifungal drug and it is completely insoluble in water. Methanol was used as solvent for solubilization of Fenticonazole Nitrate. Maximum absorption for Fenticonazole Nitrate was found to be at wavelength 253 nm when dissolved in Methanol. 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 242-262 nm. The drug followed linearity in the concentration range of 5 - 30µg/mL with correlation coefficient value r> 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.