Determination of 11 N-nitrosamine Impurities in Cimetidine Tablets by HPLC-MS/MS
Objective:To determine 11 N-nitrosamine impurities in Cimetidine tablets by HPLC-MS/MS.Methods The separation of impurities was performed by ACE EXCEL3 C18-AR(4.6 mm×250 mm,3 μm)with the mobile phase 0.1%formic acid solution(A)-methanol solution(B)by gradient at a flow rate was 0.8 mL·min-1.Multiple reaction monitoring was performed on a triple mass spectrometer equipped with an APCI source in the positive mode.Results Under the selected conditions,the calibration curves were in good linearty at 1 ng∙mL-1～500 ng∙mL-1 for 11 N-nitrosamine impurities.The recoveries were within 80.81%～105.13%with RSD under 4.0%.Conclusion The present method has the advantages of simple operation,highly sensitive and good reproducibility,and can simultaneously determine 11 N-nitrosamine impurities in ranitidine hydrochloride capsules.
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