Quantitative 1H-NMR Method for the Determination of Tadalafil in Bulk Drugs and its Tablets
Qingyun Yang | Hui Qiu | Wei Guo | Dongmei Wang | Xingning Zhou | Dan Xue | Jinlan Zhang | Song Wu | Yinghong Wang
A simple, rapid, accurate, and selective quantitative nuclear magnetic resonance method for the determination of tadalafil in bulk drugs and its tablets was established and evaluated. Spectra were obtained in dimethylsulfoxide-d6 using 2,4-dinitrotoluene as the internal standard. In this study, the method’s linearity, range, limit of quantification, stability, precision, and accuracy were validated. The results were consistent with those obtained from high-performance liquid chromatography analysis. Thus, the proposed method is a useful and practical tool for the determination of tadalafil in bulk drugs and its tablets.
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