Development of a Sensitive High Resolution Mass Spectrometry Method for Quantitation of N-Nitrosamines using Tof MRM on the Xevo G2-XS QTof

Význam tématu

N-nitrosamines are recognized as potential human carcinogens found in water, tobacco and pharmaceutical products. Monitoring at sub ng/mL levels is crucial for ensuring public safety and meeting regulatory standards.

Cíle a přehled studie

This study aimed to develop a high resolution MS method using Tof MRM on a Xevo G2-XS QTof combined with UPLC separation. Six priority N-nitrosamines (NDMA, NDEA, NMBA, NDBA, NEIPA, NDIPA) were targeted to achieve limits of quantification at or below 0.1 ng/mL, with robust performance and compliance readiness.

Použitá metodika a instrumentace

• UPLC separation on ACQUITY UPLC I-Class with HSS T3 column
• Ionization via Ion Sabre II APCI probe
• Detection on Xevo G2-XS QTof in Tof MRM acquisition mode
• Data acquisition, processing and GxP compliance handled by UNIFI Scientific Information System
• Targeted precursor isolation in quadrupole followed by collision induced dissociation and signal enhancement in TOF region

Hlavní výsledky a diskuse

The method delivered sub-ng/mL LODs and LLOQs for all six analytes with calibration linearity spanning 0.01–100 ng/mL and R² values above 0.995. QC samples at 1.25 and 12.5 ng/mL for NDMA and NDEA showed accuracies within 15% and repeatabilities (RSD) below 7%, confirming reliable quantitative performance.

Přínosy a praktické využití metody

• High sensitivity and selectivity for trace-level analysis in complex matrices
• Accurate mass confirmation reduces risk of false positives
• Compliant workflow suitable for pharmaceutical quality control
• Simultaneous quantitation of multiple nitrosamines in a single analysis

Budoucí trendy a možnosti využití

Future developments may include extending the method to additional nitrosamine analogues and diverse sample types such as environmental waters and food products. Integration with automated sample preparation and advanced data analytics could increase throughput and expand screening capabilities in regulatory and research laboratories.

Závěr

The UPLC ToF MRM workflow on the Xevo G2-XS QTof provides a sensitive, selective and GxP-compliant platform for quantifying six priority N-nitrosamines at sub-ng/mL levels. The method meets stringent regulatory demands and supports routine laboratory use.

Reference

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