Development and validation of a simple and sensitive high performance liquid chromatographic method for the simultaneous determination of anastrozole, bicalutamide, tamoxifen, and their synthetic impurities

► A total separation of the compounds was successfully achieved. ► Statistic models were successfully applied on the validation of the method. ► No interference peaks from excipients indicated the specificity of the method. ► The results obtained from the validation met the requirements of ICH and USP. ► The method is suitable for routine quality control analysis.