AS239: Full Method Validation of an Automated Solution for Nitrosamines in Irbesartan and Metformin by LC-MS-MS Analysis

Martin Perkins

24th September 2020

Automated Nitrosamines Analysis:

This application note follows the preliminary work undertaken at Element 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).

The inherent benefits of automated sample preparation, including convenience, reduced environmental exposure, and improved accuracy and precision are clearly demonstrated, alongside the significant benefit of high throughput unattended operation.

This solution will be of interest to pharmaceutical drug substance and drug product manufacturers to support their research, process development and quality control programs. CRO organisations offering outsourced, high throughput, testing will also benefit greatly from the quality and efficiency gains associated with this automated analysis.