Determination of genotoxic impurity in atazanavir sulphate drug substance by LC-MS

A sensitive LC-MS method was developed for the determination of tert-butyl 2-[4-(pyridine-2-yl) benzyl] hydrazine carboxylate (GTI-A), a genotoxic impurity in Atazanavir sulphate drug substance. The method was validated as per International Council for Harmonization guidelines, for QL, DL, linearity and accuracy. The QL and DL values obtained were 1.1 ppm and 0.3 ppm respectively. The Correlation coefficient found for the linearity study was 0.999. The % recovery of the added impurity in the range of 96.4-100.4 ensured the accuracy of the method.