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Generic workflow using advanced analysis and data interpretation tools for identification of Irbesartan degradation products by liquid chromatography coupled to high resolutionmass spectrometry

Anoop Kumar, Ganesh Darekar, Suma Ramagiri, Neha Bhasin

A high performance liquid chromatography (HPLC) coupled AB SCIEX TripleTOFTM 5600 high resolution mass spectrometer system was used for identification of degradation products (DPs) of Irbesartan using generic workflow. Degradation experiments were carried out under various conditions such as acid hydrolysis, acid photolysis, base hydrolysis and base photolysis. Asimple reverse phase chromatography was developed to separate the degradation products or impurities on PhenomenexKinetics C18 (50 x 2.10mm,1.7µ) column using 5mM ammonium acetate and methanol at 0.5 ml/ min flow rate. Degradation products of Irbesartan were acquired using generic information dependent acquisition (IDA) with dynamic background substraction algorithm (DBS). The major degradation products were identified as 2-butyl-3-(tetrazole[1,5-f] phenanthridin-6-ylmethyl)-1,3- diazaspiro[4,4]non-1-en-4-one (m/z 427.2251; C25H27N6O+) and 1-(1-2-(1Htetrazol- 5-yl)biphenyl-4-yl) methylamino) pentylideneamino) cyclopentane carboxylic acid (m/z 447.2506; C25H31N6O2 +), acid photolysis and base hydrolysis stress condition, respectively.