Estimation of Tadalafil Using Derivative Spectrophotometry in Bulk Material and in Pharmaceutical Formulation

Z. Khan, A. Patil, A. Shirkhedkar
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引用次数: 11

Abstract

Four simple, rapid, accurate, precise, reliable, and economical UV-spectrophotometric methods have been proposed for the determination of tadalafil in bulk and in pharmaceutical formulation. “Method A” is first order derivative UV spectrophotometry using amplitude, “method B” is first order derivative UV spectrophotometry using area under curve technique, “method C” is second order derivative UV spectrophotometry using amplitude, and “method D” is second order derivative UV spectrophotometry using area under curve technique. The developed methods have shown best results in terms of linearity, accuracy, precision, and LOD and LOQ for bulk drug and marketed formulation as well. In N,N-dimethylformamide, tadalafil showed maximum absorbance at 284 nm. For “method A” amplitude was recorded at 297 nm while for “method B” area under curve was integrated in the wavelength range of 290.60–304.40 nm. For “method C” amplitude was measured at 284 nm while for “method D” area under curve was selected in the wavelength range of 280.80–286.20 nm. For methods A and B, tadalafil obeyed Lambert-Beer’s law in the range of 05–50 μg/mL while for “methods C and D”, tadalafil obeyed Lambert-Beer’s law in the range of 20–70 μg/mL, and-for “methods A, B, C, and D” the correlation coefficients were found to be  than 0.999.
导数分光光度法测定原料药和制剂中他达拉非的含量
建立了四种简便、快速、准确、精密度、可靠、经济的紫外分光光度法测定原料药和制剂中他达拉非的方法。“方法A”是采用幅度法的一阶导数紫外分光光度法,“方法B”是采用曲线下面积法的一阶导数紫外分光光度法,“方法C”是采用幅度法的二阶导数紫外分光光度法,“方法D”是采用曲线下面积法的二阶导数紫外分光光度法。所开发的方法在原料药和上市制剂的线性度、准确度、精密度以及LOD和LOQ方面均显示出最佳结果。在N,N-二甲基甲酰胺中,他达拉非在284 nm处的吸光度最大。方法A在297 nm处记录振幅,方法B在290.60 ~ 304.40 nm范围内积分曲线下面积。方法C在284 nm处测量振幅,方法D在280.80 ~ 286.20 nm范围内选择曲线下面积。方法A、B在05 ~ 50 μg/mL范围内符合兰伯特-比尔定律,方法C、D在20 ~ 70 μg/mL范围内符合兰伯特-比尔定律,方法A、B、C、D的相关系数均大于0.999。
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