Analytical instrument qualification and system validation according to USP Chapter <1058> for the Agilent 1290 Infinity LC system

According to USP Chapter <1058> analytical instruments must be qualified before use. This Application Note will show a setup for testing the Agilent 1290 Infinity LC System. Metoclopramide was chosen as example substance to acquire data for testing accuracy, precision, and linearity and the results are presented. The results of independent gradient testing with the Jet Weaver show steep gradient shapes and high plateau accuracy. The setup for different columns to achieve comparable separations starting with 5 μm material (250 mm × 4.6 mm), 3.5 μm material and columns with sub-2 μm materials of different vendors are shown. This versatility makes the system applicable for standard LC methodology as well as where highest separation power is needed. The results for the determination of the precision of areas (<2% required), and retention times (<0.05% required) show that all criteria for qualified instruments are fulfilled. The coefficients for linearity for all components are better than 0.999. No carryover was detected. Authors Detlef Wilhelm ANATOX GmbH & Co. KG Fuerstenwalde Germany Edgar Naegele Agilent Technologies Waldbronn, Germany Application Note Pharmaceutical QA/QC