Quantitative Method For Determination Of 3,3-Dimethylallyl Bromide Genotoxic Impurity In Tazarotene Drug Substance By Gc-Ms

A highly sensitive gas chromatography-mass spectrometry quantitative method was developed for 3,3-dimethylallyl bromide genotoxic impurity in the tazarotene drug substance. The method was validated by following the International conference for harmonization Q2 (R1) guideline for the limit test of 3,3-dimethylallyl bromide genotoxic impurity in the tazarotene drug substance. The 148 m/z, 150 m/z, and 69 m/zions were selected to get a response in mass spectrometry for 3,3-dimethylallyl bromide. DB-1 (30 mm x 0.25 x 1.0 mu m) column was used for the separation of 3,3-dimethylallyl bromide from the sample matrix. The limit of detection and limit of quantitation for 3,3-dimethylallyl bromide in this method was 0.7 and 2.1 ppm, respectively. The method was precise and accurate at limit of quantitation level, 1.7% RSD was observed at limit of quantitation precision and 100.9% recovery observed at limit of quantitation accuracy, it was linear from the 5 to 20 mu g/L, the correlation coefficient (r) was 0.9996.