Quotient Sciences  presented a poster at the European Bioanalysis Forum (EBF) conference in November 2021, describing an assay that their Bioanalysis team built to determine six pharmaceutically relevant N-nitrosamines in both drug substances and drug products. The assay was applied to determine N-nitrosamines in three different ranitidine reference materials.
Samples of N-nitrosamines were extracted from each ranitidine reference material using liquid-liquid extraction (LLE). Three different concentration levels for each N-nitrosamine were used to construct calibration curves. The N-nitrosamines were separated by liquid chromatography (LC) and detected by tandem mass spectrometry (MS/MS).
Of the six N-nitrosamines included in the assay, only one of them, N-nitrosodimethylamine (NDMA), was found at concentrations greater than the assay lower limit of quantification (LLOQ) in the ranitidine reference materials. NDMA was detected in all three of the reference materials, but the concentrations that were found differed greatly between them. Overall, the assay was successful and could quantify the presence of NDMA in ranitidine.
1. Michael Blackburn, Daniel Vidler, Hannah Gent, Elizabeth Linsley, Stuart McDougall
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