Determination of Potential Genotoxic Impurities (Orthophenylene Diamine Dihydrochloride), 4'-Bromomethyl-2-Cyanobiphenyl, 4'(Dibromomethyl)[1,1'-Biphenyl]-2-Carbonitrile in Telmisartan by ESI-MS/MS.

A sensitive, simple, rapid and robust LC-MS/MS method was developed for the determination of potential genotoxic impurities OPDA HCl (orthophenylene diamine dihydrochloride), bromo OTBN (4'-bromomethyl-2-cyanobiphenyl), dibromo (4'(dibromomethyl)[1,1'-biphenyl]-2-carbonitrile) in Telmisartan by using ESI-MS/MS Technic; the study was performed with gradient elution (time/% mobile phase B: 0/10, 3/10, 30/80, 35/80, 36/10, 40/10). The mobile phase consisted of a mixture of formic acid, methanol and acetonitrile. The buffer was degassed before running at a flow rate of 1.