A solvent-free headspace GC/MS method for sensitive screening of <i>N</i>-nitrosodimethylamine in drug products
Do Hee Lee, Su Hyeon Hwang, Seoungchul Park, Jeongmi Lee, Han Bin Oh, Sang Beom Han, Kwang-Hyun Liu, Yong‐Moon Lee, Hee Soo Pyo, Jongki Hong
Abstract
and matrix effects ranged from 0.97 to 1.11. The accuracy ranged from 92.77 to 106.54% and the precision RSDs were below 5.94%. No significant matrix effect was observed for any of the drug products. Also, artefactual NDMA formation in ranitidine, nizatidine, and metformin was investigated under HS conditions. Adjusted (mild) SF-HS conditions were suggested for precise quantification of NDMA in positive drug products by GC/MS. The present SF-HS-GC/MS method is a promising tool for the screening and determination of toxic NDMA in APIs and drug products.
Topics & Concepts
N-NitrosodimethylamineChromatographyChemistrySolventGas chromatography–mass spectrometryDrugMass spectrometryOrganic chemistryPharmacologyBiologyCarcinogenWater Treatment and DisinfectionNeuroscience of respiration and sleepAdvanced Chemical Sensor Technologies