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 & 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.
Highlights
Safety and efficacy of pharmaceutical substances are the two fundamental issues in drug therapy
Irbesartan was in-house synthesized at Indian Institute of chromatography and Mass Spectrometry (IICMS), Chennai, India for academic research
Though a three-step process is used to synthesize Irbesartan, the HPLC analysis shows the presence of five impurities, whose concentration varies from 0.04% to 0.32% Area
Summary
Safety and efficacy of pharmaceutical substances are the two fundamental issues in drug therapy. The safety of a drug is determined by its pharmacological or toxicological profile as well as the adverse effects caused by the impurities in bulk and dosage forms. The quality and safety of a drug is generally assured by monitoring it using suitable analytical techniques and controlling the Impurities effectively. The analytical activities concerning impurities in drugs are among the most important aspect in the modern pharmaceutical analysis [1,2,3,4,5]. The impurity profiling is considered to be the analytical activities with the aim of detecting, identifying or elucidating the structure and quantitatively determining impurities in bulk drugs and pharmaceutical formulations [6,7,8,9,10]
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