HPLC Method for Analysis of N-Nitrosodiethylamine on Newcrom R1 Column

N-Nitrosodiethylamine (NDEA) or Diethylnitrosamine is potential carcenogenic agent was found in some blood pressure medications. Those medications were recalled by FDA with the concern of high concentration of the chemical. SIELC developed simple and fast HPLC method to measure presence of NDEA in drug formulations. This UV based method allows to detect ppb level of the compound in solution. Simple mobile phase comprised of acetonitrile (MeCN) and water with detection at 2** nm using Newcrom R1 column can be used to detect both the API and the NDEA.  

Condition

Column Newcrom R1, 4.6x150 mm, 5 µm, 100A
Mobile Phase MeCN - 20-80%
Buffer No
Flow Rate 1.0 ml/min
Detection UV, 232 nm
 

Description

Class of Compounds Carcinogen, Zwitterionic, Hydrophobic
Analyzing Compounds NDMA
 

Application Analytes:

N-Nitrosodiethylamine
Valsartan