ABSTRACT
Objective: The mass characterization of five trace level related impurities of Irbesartan was performed through the “nMS2” technique of triple quadrupole mass spectrometer and also to Correlated to the impurity origin. Methods: A simple and effective patented process was applied to get the impurity profile, and mass characterization was performed through the “nMS2” technique of triple quadrupole mass spectrometer analyser. Results: The simple production scan in differential collision energies is coined as “nMS2” technique of the triple quadrupole analyzer. The molecular ion fragmentation occurs with multiple collision energies and provides meaningful MSMS fragments for characterizing five trace level impurities less than 0.5% of angiotensin II receptor antagonist-Irbesartan. The origin of the impurity formation in the synthetic process was successfully related to the Spiro ketones. Conclusion: The results obtained in this research clearly indicates the approach of “nMS2” technique was very useful in the identification and structural prediction of trace level related impurities of Irbesrtan.