Journal of pharmaceutical and biomedical analysis
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J Pharm Biomed Anal · Nov 2020
HS-SPME-GC-MS as an alternative method for NDMA analysis in ranitidine products.
N-nitrosodimethylamine (NDMA) is a carcinogenic contaminant that was accidentally discovered in drugs, such as valsartan and ranitidine, and more recently in metformin. Liquid chromatography tandem mass spectrometry (LC-MS/MS) is the method typically used for the analysis of NDMA in ranitidine. It seems that using gas chromatography (GC) for NDMA analysis is problematic as ranitidine is sensitive to high temperatures. ⋯ Interestingly, using HS-SPME-GC-MS was advantageous because we could avoid the high temperature utilized in the liquid injection and HS modes. Moreover, the results obtained using HS-SPME-GC-MS provided a good match with those achieved using LC-MS/MS. The feasibility of using HS-SPME-GC-MS to successfully analyze NDMA in ranitidine opens new opportunities for the analysis of this contaminant in pharmaceuticals, specifically those that are heat-labile.