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.

 

 

Condition

Column Newcrom R1, 4.6×150 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

 

Description

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

 

Application Column

Newcrom R1

The Newcrom columns are a family of reverse-phase-based columns. Newcrom A, AH, B, and BH are all mixed-mode columns with either positive or negative ion-pairing groups attached to either short (25 Å) or long (100 Å) ligand chains. Newcrom R1 is a special reverse-phase column with low silanol activity.

Select options
Application Analytes:
N-Nitrosodiethylamine
Valsartan
SIELC Technologies usually develops more than one method for each compound. Therefore, this particular method may not be the best available method from our portfolio for your specific application. Before you decide to implement this method in your research, please send us an email to research@sielc.com so we can ensure you get optimal results for your compound/s of interest.