Identification of Irbesartan Degradation Products using New Hybrid Quadrupole Time-of-Flight Tandem Mass Spectrometry System

摘要

A high performance liquid chromatography (HPLC) coupled to AB SCIEX TripleTOF 5600 mass spectrometer system was used for identification of degradation products (DPs) of Irbesartan. Degradation experiments were carried out under acid hydrolysis, acid photolysis, base hydrolysis and base photolysis stress conditions. A simple reverse phase chromatography was developed to separate the degradation products or impurities on Phenomenex Kinetics C18 (50 × 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) workflows with noval on fly dynamic background substraction (DBS) algorithm. 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)N_6O~+) and 1-(1-2-(1H-tetrazol-5-yl)biphenyl-4-yl) methylamino) pentylideneamino) cyclopentane carboxylic acid (m/z 447.2506; C_(25)H_(31)N_6O_2~+) in acid photolysis and base hydrolysis stress condition, respectively using generic IDA workflow.