This application note follows the preliminary work undertaken at Anatune to address the measurement of a wide range of nitrosamines in drug substance as outlined in Application Note AS234. Here we demonstrate the optimisation and validation of a fully automated solution for the sample preparation and LC-MS/MS analysis of seven target nitrosamines in two classes of drug substance, Irbesartan (angiotensin II receptor antagonist) and Metformin (biguanide analogue antidiabetic). This optimised and validated analytical solution clearly indicates the benefits of automated sample preparation for complex analyses in terms of improved analytical performance, protection from contamination and convenience.
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Full Method Validation of an Automated Solution for Nitrosamines in Irbesartan and Metformin by LC-MS-MS Analysis