Method for detecting impurity elements in sodium ozagrel

Abstract

The invention discloses a method for detecting impurity elements in sodium ozagrel. The detection method comprises the following steps: (1) testing the response ratio of impurity elements to internal standard elements in a reference substance solution by adopting inductively coupled plasma mass spectrometry, and obtaining a linear equation; (2) testing the response ratio of the impurity element to be tested to the internal standard element in the test solution, and substituting the response ratio into the linear equation; the target impurity elements comprise Li, Sb, Cu, V, Co, Ni, As, Cd, Hg and Pb; the concentration of the sample to be detected in the test solution is 0.1-0.4 mg / mL; the preparation method of the test solution comprises the following steps: digesting a mixed solution of a to-be-detected sample and nitric acid, and diluting, wherein the mass volume ratio of the to-be-detected sample to the nitric acid is 5-8 mg / mL. According to the detection method, the content of various impurity elements in sodium ozagrel can be rapidly, effectively and simultaneously detected, the stability is good, and the detection is efficient.

Description

technical field [0001] The invention relates to a method for detecting impurity elements in ozagrel sodium. Background technique [0002] Ozagrel sodium (ozagrel sodium), the chemical name is trans-3-[4-(1H-imidazole-1-methyl)phenyl]-2-sodium acrylate, which was established by Japan Ono Pharmaceutical Co., Ltd. in 1989. The first thromboxane synthase (TX) inhibitor launched on the market under the trade name Cataclot has anti-platelet aggregation and anti-vascular effects, and is used for the treatment of cerebral thrombosis and accompanying movement disorders. In the process of preparing sodium ozagrel, it is inevitable to introduce trace amounts of heavy metal elements. As we all know, heavy metal elements are slowly metabolized in the human body and are easy to accumulate, causing harm to the human body. [0003] However, it has not been reported how to detect the heavy metal elements contained in the bulk drug of sodium ozagrel, and this problem has not yet been resolve...

AI Technical Summary

Problems solved by technology

In the process of preparing sodium ozagrel, it is inevitable to introduce trace amounts of heavy metal elements. As we all know, heavy metal elements are slowly metabolized in the human body, easy to accumulate, and cause harm to the human body.

[0003] However, it has not been reported how to detect the heavy metal elements contained in the bulk drug of sodium ozagrel, and this problem has not yet been resolved.

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