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

摘要

A high performance liquid chromatography (HPLC) coupled AB SCIEX TripleTOF? 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. A simple reverse phase chromatography was developed to separate the degradation products or impurities on Phenomenex Kinetics C18 (50 x2.10 mm, 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; C_(25)H_(27)N6O~+) and 1-(1-2-(lH-tetrazol-5-yl)biphenyl-4-yl) methylamino) penrylideneamino) cyclopentane carboxylic acid (m/z 447.2506; C_(25)H_(31)N6O2~+), acid photolysis and base hydrolysis stress condition, respectively.