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
HPLC Analysis of Drug Valsartan on Heritage C18 Column
Conditions of Experiment
Column: Heritage C18
Separation Modes: reversed-phase
Column Dimenstions: 4.6 x 250 mm, 5 um, 100A
Mobile Phase: 50% ACN with 20 mM NaH2PO4 pH 2.5
Detection: UV 254 nm
Sample: 0.2 mg/ml
Injection: 5 uL
Flow rate: 1 ml/min
Class of compounds: Drug
Nature of compounds: Acidic, Hydrophobic
Compounds: Valsartan