In silico toxicity assessment and trace level quantification of two genotoxic impurities in silodosin using capillary gas chromatography

Abstract A capillary gas chromatographic method using flame ionization detection was developed and validated for the trace quantification of 2-bromoethanol (2-BE) 2-bromoethylmethanesulfonate (2-BEM) in silodosin, used treatment benign prostatic hyperplasia. Chromatographic separation performed spilt mode nitrogen as carrier on a column containing crosslinked polyethylene glycol (30 m × 0.32 mm, 0.25 µm) stationary phase modified with nitroterephthalic acid. simple matrix precipitation strategy implemented to eliminate sample overload interference problems. The linear accurate concentration range 24–3000 ppm 2-BE 24–300 2-BEM r 2 ˃ 0.999 percent recoveries greater than 90% both analytes. precise analytes RSD(%) not more 4.5%. In silico genotoxicity carcinogenicity potential were assessed ICH M7 principles. can be applied quality control laboratories pharmaceutical industries level silodosin.