Valsartan

CAS Number 137862-53-4
Molecular Formula C24H29N5O3
Molecular Weight 435.528 g/mol
InChI Key ACWBQPMHZXGDFX-QFIPXVFZSA-N
LogP 4.4
Synonyms
  • valsartan
  • Diovan
  • Provas
  • Tareg
  • L-Valsartan
  • CGP 48933
  • Exforge
  • Kalpress
  • Miten
  • Nisis
  • Vals
  • (S)-2-(N-((2'-(1H-Tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)pentanamido)-3-methylbutanoic acid
  • CGP-48933
  • Valsarran
  • Valsartan [USAN:INN]
  • [3H]valsartan
  • UNII-80M03YXJ7I
  • Diovan (TN)
  • N-(p-(o-1H-Tetrazol-5-ylphenyl)benzyl)-N-valeryl-L-valine

Applications:


HPLC Method for Analysis of Valsartan
Chr_1051

Valsartan is a nonpeptide triazole-derived antagonist of angiotensin that selectively and competitively blocks the binding of angiotensin II to the AT1 subtype receptor. It is used to treat high blood pressure and heart failure, as well as to improve the chance of someone living longer after a heart attack. Primesep 200, a reverse phase column, contains embedded acidic ionizable groups and can retain Valsartan. The method is UV compatible and can be used as a general approach for analyzing similar compounds.

Application Analytes:

Valsartan

HPLC Analysis of Valsartan
Valsartan is a drug commonly used to treat high blood pressure and congestive heart failure. Legacy L1 was used to retain valsartan by reverse phase mechanism in this HPLC separation method. Legacy L1 uses embedded C18 groups on porous silica and is useful for many USP HPLC applications. Comparisons to Phenomenex columns are available by request. This simple HPLC method can be used in many pharmaceutical areas. For example, in batch production, impurity profiling, formulation and pharmacokinetics.

Condition

Column Legacy L1, 4.6x250 mm, 5 µm, 100A
Mobile Phase MeCN - 50%
Buffer NaH2PO4  pH 2.5 - 20 mM
Flow Rate 1.0 ml/min
Detection UV, 254 nm
   

Description

Class of Compounds  Drug,  Hydrophilic, Ionizable
Analyzing Compounds Valsartan
 

Application Analytes:

Valsartan

HPLC Method for Analysis of N-Nitrosodiethylamine on Newcrom R1 Column
N-Nitrosodiethylamine (NDEA) or Diethylnitrosamine is potential carcenogenic agent was found in some blood pressure medications. Those medications were recalled by FDA with the concern of high concentration of the chemical. 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 2** nm using Newcrom R1 column can be used to detect both the API and the NDEA.  

Condition

Column Newcrom R1, 4.6x150 mm, 5 µm, 100A
Mobile Phase MeCN - 20-80%
Buffer No
Flow Rate 1.0 ml/min
Detection UV, 232 nm
 

Description

Class of Compounds Carcinogen, Zwitterionic, Hydrophobic
Analyzing Compounds NDMA
 

Application Analytes:

N-Nitrosodiethylamine
Valsartan

HPLC Method for Detection of NDMA 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). This impurity 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, 4.6x150 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
 

Description

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

Application Analytes:

N-Nitrosodiethylamine
Valsartan