Sorafenib tosylate content determination method based on nuclear magnetic resonance quantitative technology

A technology of toluenesulfonic acid and sorafenib, which is applied in the field of determination of sorafenib toluenesulfonate content based on NMR quantitative technology, can solve the problems of complicated and cumbersome experimental process, and achieve simple sample processing, time-saving and exclusive The effect of high sex and sensitivity

Pending Publication Date: 2022-02-15
北京绿谱科技有限公司
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  • Application Information

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Problems solved by technology

[0005] The present invention proposes a method for determining the content of sorafenib tosylate based on nuclear magnetic resonance quantitative technology, which solves the problem that the experimental process of high performance liquid chromatography in the prior art is relatively complicated and cumbersome

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  • Sorafenib tosylate content determination method based on nuclear magnetic resonance quantitative technology
  • Sorafenib tosylate content determination method based on nuclear magnetic resonance quantitative technology
  • Sorafenib tosylate content determination method based on nuclear magnetic resonance quantitative technology

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Embodiment 1

[0028] A kind of Sorafenib tosylate content assay method based on nuclear magnetic resonance quantitative technology, comprises the following steps:

[0029] S1. Preparation of internal standard solution: Accurately weigh 55.2 mg of hydroquinone into a 10 mL volumetric flask, constant volume with deuterated dimethyl sulfoxide, and record the obtained solution as hydroquinone internal standard solution;

[0030] S2, need testing solution: weigh the sorafenib tosylate crude drug and add 0.6mL hydroquinone internal standard solution and fully mix, the obtained sorafenib tosylate solution concentration is not higher than 20.0mg / ml, The resulting solution is then transferred to an NMR tube to be tested;

[0031] S3, nuclear magnetic resonance spectrum determination: adopt hydrogen nuclear magnetic resonance spectrum quantitative method, with the deuterated dimethyl sulfoxide in the obtained sorafenib tosylate solution in step 2 as solvent, hydroquinone as internal standard for quan...

Embodiment 2

[0033] The difference between this embodiment and embodiment 1 is:

[0034] The relaxation delay time (d1) is 1s, and the sampling time (aq) is 10min.

Embodiment 3

[0036] The difference between this embodiment and embodiment 1 is:

[0037] The relaxation delay time (d1) is 5s, and the sampling time (aq) is 16min.

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Abstract

The invention belongs to the technical field of sorafenib tosylate determination, and particularly relates to a sorafenib tosylate content determination method based on a nuclear magnetic resonance quantitative technology. The objective of the invention is to solve the problem that the experimental process of high performance liquid chromatography determination in the prior art is complex and tedious. According to the invention, the sorafenib tosylate content determination method based on a nuclear magnetic resonance quantitative technology comprises the following steps: preparing an internal standard solution: precisely weighing 55.2 mg of hydroquinone in a 10mL volumetric flask, fixing the volume by using deuterated dimethyl sulfoxide, and marking the obtained solution as the hydroquinone internal standard solution; and supplying test sample solution: nuclear magnetic resonance spectrum determination: determining sorafenib tosylate by adopting a nuclear magnetic resonance hydrogen spectrum quantitative method. According to the invention, the sorafenib tosylate content is measured by adopting a Q1HNMR method, the sample is not damaged, and the sample treatment is simple.

Description

technical field [0001] The invention relates to the technical field of sorafenib tosylate determination, in particular to a method for determining the content of sorafenib tosylate based on nuclear magnetic resonance quantitative technology. Background technique [0002] Sorafenib tosylate tablets (product name: Nexavar), a clinical anticancer agent for the treatment of liver and renal cell carcinoma. [0003] Due to the unique characteristics of NMR technology, that is, no reference substance is needed, the pretreatment is simple, non-selective to samples, destructive and easy to operate, etc., it is widely used in the qualitative and quantitative determination of drugs. In order to establish an efficient, A rapid, precise and accurate method for determining the content of sorafenib tosylate. This article chooses Q 1 HNMR (hydrogen nuclear magnetic resonance spectrum) measures the content of sorafenib benzenesulfonate. After a series of NMR qualitative experiments of sor...

Claims

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Application Information

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IPC IPC(8): G01N24/08
CPCG01N24/082
Inventor 智涵赵玉婧刘君
Owner 北京绿谱科技有限公司
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