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.
A novel High-Performance Thin-Layer Chromatography (HPTLC) method was portrayed for the determination of Fenticonazole Nitrate (FTZ) in Bulk and Vaginal Capsules. The estimation of Fenticonazole Nitrate was achieved on aluminium pre-coated sheets of silica gel 60 F(10 cm × 10 cm) using mobile phase Toluene: Methanol: Triethylamine (4:1:0.5 v/v/v). Densitometry detection of Fenticonazole Nitrate was performed at 254nm. Fenticonazole nitrate demonstrated a strong correlation with a coefficient of correlation of 0.999 over the concentration range of 500 – 3000 ng/band. The Rvalue for Fenticonazole Nitrate was found to be 0.65. As per International Conference on Harmonization the established method was successfully validated to various parameters like accuracy, precision, sensitivity, specificity, robustness and shows the satisfactory results for all parameters. The recognized method is simple, accurate, precise, robust, sensitive and economical in nature. This method can be used for quality control analysis of Fenticonazole Nitrate in bulk and vaginal capsules.
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