Liquid Chromatography-Tandem Mass Spectrometry (LCMS/MS)

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) represents the pinnacle of analytical sensitivity and specificity for complex pharmaceutical and biological matrices. The technique couples HPLC separation with the selectivity of triple-quadrupole mass spectrometry operating in Multiple Reaction Monitoring (MRM) mode — monitoring the transformation of a specific precursor ion to specific product ions unique to each analyte. This two-stage mass filtering eliminates virtually all matrix interferences, enabling quantification at concentrations as low as parts-per-trillion.

The rise of nitrosamine impurity concerns (NDMA, NDEA, NMBA, and related genotoxic impurities) has driven significant LC-MS/MS investment across pharmaceutical testing. ICH M7 classifies nitrosamines as probable human carcinogens with acceptable intake (AI) limits as low as 18 ng/day for NDMA. These trace levels require LC-MS/MS or GC-MS/MS. Auriga validated nitrosamine testing methods meet FDA, EMA, and CDSCO guidance requirements.

Beyond nitrosamines, LC-MS/MS at Auriga supports pharmaceutical bioanalytical studies for clinical trials, genotoxic impurity testing per ICH M7, mycotoxin analysis in food products, and multi-residue pesticide testing. Bioanalytical applications are particularly critical for clinical trial work, where accurate plasma drug concentration measurement forms the pharmacokinetic evidence base for BA/BE study regulatory submissions.