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Method for determining a genotoxic impurity m-trifluoromethyl phenylpropanal dimer in cinacalcet hydrochloride tablet

A technology of trifluoromethyl phenylpropanal dimer and cinacalcet hydrochloride tablets, which is applied in the directions of measuring devices, instruments, scientific instruments and the like to achieve the effects of good precision and good accuracy

Pending Publication Date: 2021-10-12
南京恒生制药有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] At present, there is no relevant literature report on the determination method of m-trifluoromethylphenylpropanal dimer

Method used

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  • Method for determining a genotoxic impurity m-trifluoromethyl phenylpropanal dimer in cinacalcet hydrochloride tablet
  • Method for determining a genotoxic impurity m-trifluoromethyl phenylpropanal dimer in cinacalcet hydrochloride tablet
  • Method for determining a genotoxic impurity m-trifluoromethyl phenylpropanal dimer in cinacalcet hydrochloride tablet

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Embodiment 1

[0052] Embodiment 1 The methodological research of detection analysis method of the present invention

[0053] Various tests in this embodiment all adopt the following conditions:

[0054] Instrument: 7890A Gas Chromatograph—μECD Electron Capture Detector

[0055] Chromatographic column: Agilent DB-1, the specification is 30m×0.32mm×1.5μm

[0056] Carrier gas flow: nitrogen, 1.0ml / min

[0057] Injection volume: 1.0μl

[0058] Split ratio: 5:1

[0059] Injection port temperature: 280°C

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Abstract

The invention discloses a method for determining a genotoxic impurity m-trifluoromethyl phenylpropanal dimer in a cinacalcet hydrochloride tablet. The determination method comprises the following steps: the content of the trifluoromethyl phenylpropanal dimer is respectively detected by adopting a gas chromatographic method, wherein the detection conditions are as follows: a detector is a gas chromatograph-electron capture detector; a chromatographic column is made of a capillary tube, and a stationary phase is polysiloxane; the carrier gas is nitrogen or argon; the column temperature is eluted in a programmed heating mode; in the detection process, the temperature of the detector is 280-300 DEG C; the sample introduction volume is 0.5 microliter to 1.5 microliter, the temperature of a sample introduction port is 270 DEG C to 290 DEG C, and in the detection process, the blowing gas flow velocity of a detector is 20 ml / min to 50 ml / min; and the concentration of the m-trifluoromethyl phenylpropionaldehyde dimer by peak area is calculated according to an external standard method. The method has the advantages of high sensitivity, good specificity, strong durability and high accuracy, and ensures the safety and reliability of the cinacalcet hydrochloride tablet.

Description

technical field [0001] The invention relates to a method for determining genotoxic impurity m-trifluoromethylphenylpropionaldehyde dimer in cinacalcet hydrochloride tablets, belonging to the technical field of drug analysis. Background technique [0002] Cinacalcet hydrochloride is a calcimimetic agent developed by NPS Pharmaceuticals in the United States. It is a specific drug for controlling hyperparathyroidism and inhibiting parathyroid hormone PTH. It has now become the first-line drug in most parts of the country, and the country has listed The medical insurance directory is used by more and more patients. [0003] The level of genotoxic impurities is one of the important factors affecting the safety and effectiveness of drugs. Therefore, how to accurately determine the content of trifluoromethylphenylpropanal dimer in cinacalcet hydrochloride tablets has become an urgent problem to be solved. The problem. [0004] m-trifluoromethylphenylpropanal dimer is the dimeriza...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 周国兴丁银花胡良明韦超
Owner 南京恒生制药有限公司
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