Development and Validation of Stability-Indicating HPLC and UPLC Methods for the Determination of Bicalutamide

Six new process related impurities (Imp-08, Imp-09, Imp-10, Imp-12, Imp-13 and Imp-14) of bicalutamide (BCT) have been reported in this paper. BCT was subjected to oxidative, acid, alkaline, hydrolytic, thermal and photolytic degradation conditions and found to degrade in alkaline condition, yielding Imp-11. Stability-indicating high-performance liquid chromatography and ultra-performance liquid chromatography methods were developed for the determination of BCT in the presence of its 14 process-related impurities and 1 degradant by using Zorbax SB phenyl column (150 × 4.6 mm × 3.5 m) and HSS T3 column (100 × 2.1 mm × 1.8 m), respectively. 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 analysis in which relative standard deviation (RSD) values for areas were found below 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 respective calibration curves were approximately 0.999. The recoveries obtained for purity (90100) and assay (98102) ensured the accuracy of the developed methods. © 2012 The Author.