LC-MS/MS | method for the determination of N-nitrosodimethylamine in ranitidine hydrochloride capsules

N-nitrosamine dimethylamine (NDMA) is a compound with an N-N=O structure that reacts with DNA to alkylate and cause cancer. The FDA has revealed that the finished gastric drug ranitidine contains nitrosamine carcinogen N-nitrosamine dimethylamine that exceeds the limit requirements, and the FDA issued an announcement to recall ranitidine products on the US market, which mentioned that the NDMA content in some products will increase over time, which may lead to higher than acceptable levels of impurities.

Many domestic and foreign pharmaceutical manufacturers have initiated recalls due to the detection of over-limit NDMA in the digestive system drug ranitidine. Therefore, regulators and manufacturers need an analytical testing method to detect N-nitrosamine dimethylamine in such drugs to effectively protect the safety of people's medications.

The LC-MS/MS method has the advantages of high sensitivity, high resolution, rapid analysis, and accurate results, which can reduce the possibility of false negatives or false positives caused by matrix interference, and can meet the strict sensitivity, specificity and accuracy requirements of drug detection. In this paper, the SP.E. EXPEC 5210 triple quadrupole LC/MS system was developed to develop an LC-MS/MS method for APCI sources for the testing and quantification of N-nitrosamine dimethylamine in ranitidine raw capsules and tablets.