Development of novel HPTLC method for determination of imidazole antifungal drug fenticonazole: Exploring hydrotropy

International Journal of Pharmaceutical Chemistry and Analysis Pub Date : 2021-07-15 DOI:10.18231/J.IJPCA.2021.016

Minakshi D. Pawara, Snehal S Pardeshi, Amol R. Gaware, A. Patil, M. V. Girase

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Abstract

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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高效液相色谱法测定咪唑类抗真菌药物非替康唑含量的研究

建立了一种高效薄层色谱法测定散装和阴道胶囊中硝酸芬康唑(FTZ)的含量。采用流动相甲苯:甲醇:三乙胺(4:1:0.5 v/v/v)，在60 F(10 cm × 10 cm)铝预涂硅胶片上对硝酸芬康唑进行了测定。在254nm处进行硝酸非替康唑的密度测定。在500 ~ 3000 ng/波段范围内，硝酸非替康唑的相关性较强，相关系数为0.999。硝酸非替康唑的Rvalue为0.65。根据国际协调会议，所建立的方法在准确性、精密度、灵敏度、特异性、鲁棒性等各参数上都得到了成功的验证，所有参数都显示出令人满意的结果。该方法简便、准确、精密度高、鲁棒性好、灵敏度高、经济性好。该方法可用于硝酸盐非替康唑散装胶囊和阴道胶囊的质量控制分析。

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International Journal of Pharmaceutical Chemistry and Analysis

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