Determination of the Genotoxic Impurity 2-Ethylphenyl Hydrazine in Etodolac by UPLC-MS/MS

A UPLC-MS/MS method was established for the determination of the genotoxic impurity 2-ethylphenyl hydrazine(2) in etodolac(1). The ACQUITY HSS T3 column(2.1 mm×100 mm, 1.8 μm) was used, and the analysis was carried out in the gradient elution mode with 0.1％ formic acid as mobile phase A, and acetonitrile containing 0.1％ formic acid as mobile phase B. Electron spray ionization(ESI), positive ion mode acquisition and selective reaction monitoring(SRM) mode was used. The m/z 137.14→108.13 was selected as qualifier transition, and m/z 137.14→120.05 was selected as quantifier transition. The results showed that it was linear for 2 in the range of 12.25-122.5 pg/ml, and the LOD and LOQ were 3.68 and 12.25 pg/ml, respectively. The average recovery(n=9) was 85.46％, with the RSD of 3.56％, which could provide a reference for the determination of 2 in 1. © 2022, Shanghai Institute of Pharmaceutical Industry. All rights reserved.