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Advancing nitrosamines analysis

Advancing nitrosamines analysis with gas chromatography

Researchers suggest full evaporation static headspace gas chromatography (FE-SHSGC) could be a universal method for the analysis of semi-volatile nitrosamines in pharmaceutical products.

Nitrosamines such as N-nitrosodimethylamine (NDMA) have become common culprits for recalls of various drug products, including sartans for hypertension, metformin for diabetes and ranitidine for heartburn. As a result, regulators require frequent testing for nitrosamines in drug substances and finished products.

However, developing a reliable nitrosamine detection method is challenging, as it must be suitable for a wide array of products, able to handle the large number of batches to be tested, and highly sensitive to meet regulatory expectations.

Typically, nitrosamines are separated from sample matrix using liquid chromatography (LC) or gas chromatography (GC) and detected by a highly sensitive and specific detector. But the equipment is often expensive, and the methods limited by sample preparation steps or their ability to effectively extract nitrosamines, extending drug release timelines.