Current work discloses the sensitive LC-MS/MS method development for the trace level determination of genotoxic impurity 2-Methyl-6-nitro aniline in Telmisartan. 2-Methyl-6-nitro aniline was determined by LC-MS/MS method in Selected ion monitoring mode (SIM) using LiChrospher RP-18 (100×4.6mm) 5.0 µm column. Gradient technique was applied for the elution of analytes using acetonitrile (mobile phase A) and 0.01M ammonium acetate buffer (mobile phase B) in different ratios. The gradient program (T/%B) was set as 0/5,2.50/15, 5.00/30, 10.00/50, 15.00/95, 20.00/95. Developed method was validated as per International Conference on Harmonization guidelines. The LOD and LOQ values found for 2-Methyl-6-nitro aniline were 0.05 µg/mL and 0.1 µg/mL. The developed method serves as a upright tool in quality control for quantitation of 2-Methyl-6-nitro aniline impurity at trace levels in Telmisartan.
Key words: 2-Methyl-6-nitro aniline, Telmisartan, Genotoxic impurities, Selected Ion Monitoring (SIM), ICH guidelines.
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