HPLC Method for Detection of NDEA in Valsartan Drug Substance

 HPLC Method for Valsartan, N-Nitrosodiethylamine on Newcrom R1 by SIELC Technologies


High Performance Liquid Chromatography (HPLC) Method for Analysis of Valsartan, N-Nitrosodiethylamine 

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 x 150 mm, 5 µm, 100 A, dual ended
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 Valsartan, N-Nitrosodiethylamine

Application Column

Newcrom R1

Column Diameter: 4.6 mm
Column Length: 150 mm
Particle Size: 5 µm
Pore Size: 100 A
Column options: dual ended

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Application Analytes:
N-Nitrosodiethylamine
Valsartan

Application Detection:
UV Detection
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.