HPLC Analysis of N-Nitrosodiethylamine in Valsartan Drug Formulation on Coresep SB Mixed-Mode Columns

Application description

It’s been discovered that some of the impurities in blood-pressure medications are cancerogenic in nature. In recent months, several drugs like Valsartan were reported for containing such cancerogenic compounds like N-Nitrosodiethylamine. Valsartan is a medication for treatment of high blood pressure, heart failure and diabetic kidney disease. Valsartan is hydrophobic and acidic in nature. It is retained on the Coresep SB column by a combination of a strong reversed-phase mechanism and a weak anion-exchange mechanism. N-Nitrosamines are polar compounds with low hydrophobicity. They are retained on the Coresep SB column by a weak reversed-phase mechanism. We have developed a robust and fast method for the determination of nitrosamines in various drug formulations. This method can be used for the analysis of API and related impurities. The retention time of API and related impurities is controlled by the amount of ACN, buffer pH and buffer concentrations. Some sample preparation might be required in case of biofluids and more complex sample matrices.

Conditions of Experiment
Column: Coresep SB
Separation Modes: reversed-phase
Column Dimenstions: 4.6x150 mm, 2.7 um, 90A
Mobile Phase: ACN gradinet from 15% to 85% in 10 min, 5 min hold. 0.1% phosphoric acid
Detection: UV 230 nm
Sample: 1 mg/ml
Injection: 3 uL
Flow rate: 1 ml/min
Class of compounds: Drug, Organic compound
Nature of compounds: Acidic, Hydrophilic, Hydrophobic, Neutral, Polar
Compounds: N-Nitrosodiethylamine, Valsartan