Abstract
The control of impurities plays a significant role for the production of high quality drug substance. In the present study, we reported a simple four step route for the synthesis of desfluoro impurity (4-(3-(4-cyano- 3(trifluoromethyl) phenyl dimethyl-2,4- dioxoimidazolidin-1-yl)-N-methyl benzamide) of enzalutamide drug with readily available raw materials and intermediate chemicals. The synthesised compound was characterized using FT-IR, NMR and mass spectral studies. Based on the spectral analysis, it was confirmed that the compound was pure with no other bye-products or side reactions formed in the synthesis route. The purity and quantity of the compound were further evaluated using HPLC analysis. Based on the HPLC analysis, it was confirmed that the compound is having a purity of 98.58 %. Hence it can be concluded that the proposed route of methodology produces highly pure compound that can be utilized as reference substance and are useful for quality control and the validation of the analytical method in the manufacture of enzalutamide.
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