HPLC Method for Detection of NDEA in Valsartan Drug Substance

Valsartan products are used to treat high blood pressure and congestive heart failure. On July 13, 2018, FDA announced a recall of valsartan tablets because of the potential for certain products to contain an impurity, N-nitrosodimethylamine (NDMA). Nitrosamine impurities is classified as a probable human carcinogen and is believed to have been introduced into the finished products as a result of the manufacturing process of the drug substance. 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 232 nm using Newcrom R1 column can be used to detect both the API and the NDEA.    


Column Newcrom R1, 4.6x150 mm, 5 µm, 100A
Mobile Phase Gradient MeCN - 10-75%, 12 min
Buffer H3PO4- 0.1%
Flow Rate 1.0 ml/min
Detection UV, 232 nm


Class of Compounds Drug, Carcinogen, Zwitterionic, Hydrophilic, Hydrophobic, Ionizable
Analyzing Compounds NDEA,  Valsartan
Application Analytes: