Online ISSN: 2577-5669

Simultaneous Determination of NDEA and NDMA in Brivaracetam Using LC-MS/MS

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Karumuru Durga Vara Prasad Reddy, Dr. Harbeer Singh
ยป doi: 10.5455/jcmr.2022.13.04.30

Abstract

N-nitrosamines, including N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA), are potent carcinogenic contaminants in pharmaceutical formulations, raising significant safety concerns. This study presents a robust and validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous determination of NDEA and NDMA in brivaracetam, a widely used antiepileptic drug. The method development involved optimizing chromatographic conditions, mass spectrometric parameters, and sample preparation techniques. Mobile Phase A (water and formic acid) and Mobile Phase B (methanol and formic acid) were prepared to ensure accurate and reproducible results. Standard solutions were meticulously prepared through serial dilutions of stock solutions to ensure consistency and reliability. The method demonstrated high specificity, accurately measuring NDEA and NDMA in the presence of other components. Precision at the limit of quantitation (LOQ) level and successful batch analysis underscored the method's suitability for routine quality control. This validated method provides a reliable approach for monitoring N-nitrosamines in brivaracetam, contributing to drug safety and regulatory compliance.

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