Nanduri, V. V. S. S. Raman published the artcileDevelopment and Validation of Stability-Indicating HPLC and UPLC Methods for the Determination of Bicalutamide, Product Details of C18H14F4N2O4S, the main research area is bicalutamide impurity determination HPLC UPLC tablet stability.
Six new process related impurities (Imp-08, Imp-09, Imp-10, Imp-12, Imp-13, and Imp-14) of bicalutamide (BCT) were reported in this paper. BCT was subjected to oxidative, acid, alk., hydrolytic, thermal, and photolytic degradation conditions and found to degrade in alk. condition, yielding Imp-11. Stability-indicating high-performance liquid chromatog. and ultra-performance liquid chromatog. methods were developed for the determination of BCT in the presence of its 14 process-related impurities and 1 degradant by Zorbax SB Ph column (150 × 4.6 mm × 3.5 μm) and HSS T3 column (100 × 2.1 mm × 1.8 μm), resp. Both the methods were validated as per International Conference on Harmonization guidelines. Quantitation limits (QL) were found be in the ranges of 0.02-0.03% for both the methods. Precision was evaluated by replicate anal. in which % relative standard deviation (RSD) values for areas were found <2.0. Linearity for the impurities was established in the range of QL to 200% of the specification level and the correlation coefficients derived from of the resp. calibration curves were approx. 0.999. The recoveries obtained for purity (90-100%) and assay (98-102%) ensured the accuracy of the developed methods. Journal of Chromatographic Science published new progress about Decomposition. 1159977-36-2 belongs to class amides-buliding-blocks, name is N-(4-Cyano-3-(trifluoromethyl)phenyl)-3-((2-fluorophenyl)sulfonyl)-2-hydroxy-2-methylpropanamide, and the molecular formula is C18H14F4N2O4S, Product Details of C18H14F4N2O4S.
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