Abstract
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.
Highlights
Nuclear magnetic resonance (NMR) is a unique structural tool and quantitative analytical technique for purity determination and reference material analysis [1,2]
The applicability of the proposed method was evaluated through several batches of drugs and tablets, and the results were compared with those obtained by Uniform Standards and Procedures (USP)
The average recoveries of tadalafil were 100.12%, 100.71%, and 99.06%, with % RSD values 1.81%, 1.78%, and 1.40% for three signals, respectively. These results indicated that the relative proportions of tadalafil and internal standard have no influence on the method accuracy considering that tadalafil was quantitatively recovered
Summary
Nuclear magnetic resonance (NMR) is a unique structural tool and quantitative analytical technique for purity determination and reference material analysis [1,2]. NMR (qNMR) mostly cover the identification and quantification of drugs and biological metabolites. QNMR does not require a high purity reference standard for the accurate quantification of the test compounds of interest. Present study provides a rapid, accurate, specific, and simple method for the assay of tadalafil using qNMR spectroscopy. Good quantitative results were obtained in the determination of tadalafil as a bulk drug and in its tablets. The applicability of the proposed method was evaluated through several batches of drugs and tablets, and the results were compared with those obtained by Uniform Standards and Procedures (USP). The method was proven to be accurate, precise, selective and linear over the assessed concentration range
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