ISSN : 2663-2187

Development and Validation of a High-Throughput Method for NDMA Quantitation in Drug Products Using Headspace–SIFT-MS

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Pragati Kumar, Habibullah Khalilullah, Suraj Mandal, Bhaskar Vallamkonda, Ankur Agrawal, Dr. Vivek Kumar Pathak, Savita Sambhaji Patil (Pol)
» doi: 10.48047/AFJBS.6.2.2024.1542-1555

Abstract

We have created and validated a high-throughput approach for assessing N-nitrosodimethylamine (NDMA) in medical items utilizing (HS-Channel MS), which is a huge step forward in pharmaceutical analysis. Due to low levels of the carcinogenic N-nitrosodimethylamine (NDMA) contamination, angiotensin receptor blockers were initially evaluated in 2018. A lot of pharmaceutical medicines with various APIs have been tested since then. In order to understand and resolve this massive problem, the industry and authorities are working together. Using methods based on gas chromatography or liquid chromatography, conventional NDMA analysis entails sluggish model analysis and complex model preparation. Selected ion flow tube mass spectrometry (Channel MS) provides a straightforward method for analyzing NDMA in gas phase using soft chemical ionization, with a quantification limit of 2 ng g−1. The novel (MHE) method allowed for the efficient and rapid quantification of NDMA from the drug substance without dissolving it, and at concentrations significantly lower than the 96-ng day−1 regulation OK consumption. A comparable study that evaluated metformin using MHE-Channel MS and a more conventional (LC-MS/MS) method also discovered excellent agreement. The novel MHE-Channel MS method may allow for more thorough testing of pharmaceutical items since it boosts the throughput of standard models by about multiple orders of magnitude.

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