LC-MRM-MS Method for the Detection and Quantification of Six Nitrosamine Impurities in Sartan (ARBs) Drugs

Here, we present LC-MS methods capable of detecting highly polar nitrosamines at 0.007 ppm in the drug product, which is lower than the specification limit for NDMA. Three different stationary phases, a highly inert pentafluoro phenyl, an aqueous stable biphenyl, and a Polar C18 phase capable of providing excellent retention of polar nitrosamines with good peak shape were used for this purpose.