Method of analyzing and determining genotoxic impurities in valsartan by HPLC

Abstract

The invention provides a method of analyzing and determining genotoxic impurities in valsartan by HPLC (high performance liquid chromatography) and belongs to the technical field of pharmaceutical analysis. The method takes phenylsilane bonded silica gel as a stationary phase and a trifluoroacetic acid aqueous solution and an acetonitrile trifluoroacetate solution as a mobile phase and adopts a gradient elution manner; and the established high performance liquid phase analysis method can accurately determine the two potential genotoxic impurities in the valsartan, namely 4'-bromoethyl-2-cyanobiphenyl (the impurity I) and 4',4'-bisbromomethy-2-cyanobiphenyl (the impurity II). The HPLC-UV (ultraviolet) method is simple to operate and short in analysis time; the sensitivity can reach 0.5ppm;a reliable basis is provided for improvement of valsartan quality standards and research of other sartan genotoxic impurities.

Description

technical field

[0001] The invention belongs to the technical field of drug analysis, and specifically discloses a HPLC method for the determination of two potential genotoxic impurities in valsartan: 4'-bromomethyl-2-cyanobiphenyl (impurity I) and 4',4 Pharmaceutical analysis method of '-dibromomethyl-2-cyanobiphenyl (impurity Ⅱ). Background technique

[0002] Valsartan, the chemical name is N-pentanoyl-N-[[2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-L- Valine, molecular formula C 24 h 29 N 5 o 3 , the molecular weight is 435.52, and its structural formula is as follows:

[0003]

[0004] Valsartan is an angiotensin Ⅱ receptor antagonist (ARB) drug, and it is the only ARB product that has three indications for hypertension, heart failure and myocardial infarction approved by the US FDA. Since it was launched in the United States in 1997, rich clinical experience has proved the antihypertensive efficacy and cardiovascular protection properties of valsartan. S...

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