Development and validation of determination of genotoxic impurity Bromoethane in Vigabatrin drug substance using head space gas chromatographic method [HS-GC]

A specific HS-GC method has been developed, optimized, and validated for the determination of genotoxic impurity Bromoethane in Vigabatrin (VGB) drug substance. Chromatographic separation of genotoxic Bromoethane impurity was achieved on DB-1 column (30 m x 0.53 mm, 5.0 mu m), consists of 100% dimethyl polysiloxane as stationary phase and passing nitrogen carrier gas. The perfor-mance of the method was assessed by evaluating the specificity, linearity, sensitivity, precision, and accuracy experiments. The estab-lished limit of detection and limit of quantification values for the genotoxic impurity was in the range of 3.57-10.80 mu g/mL. The correla-tion coefficient value of the linearity experiment was 0.9880. The average recoveries for the accuracy were in the range of 95.3-106.8%. The results proved that the method is suitable for the determination of Bromoethane content in Vigabatrin.