Title : Development and validation of quantitative analysis using head space gas chromatographic method [HS-GC] of genotoxic impurity bromoethane in vigabatrin drug substance
Abstract:
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 (30m × 0.53 mm, 5.0 μm), consisting of 100% dimethyl polysiloxane as stationary phase and passing nitrogen carrier gas. The performance of the method was assessed by evaluating the specificity, linearity, sensitivity, precision, and accuracy of experiments. The established limit of detection and limit of quantification values for the genotoxic impurity was in the range of 3.57–10.80 μg/ mL. The correlation coefficient value of the linearity experiment was 0.9880. The average recoveries for 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.
Audience Take Away Notes:
- The audience will get exposed to new method development for quantitative analysis of genotoxic impurity Bromoethane in Vigabatrin drug substance.
- A new method can be used for the evaluation of impurity by HS-GC.
- Yes, this work could be used to expand their research and training.
- Validation of this method worked in this research article will provide great accuracy of quantitative analysis for reliable quantitative analysis of the impurity.
