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Method for detecting potential genotoxic impurities of esomeprazole sodium

A technology of esomeprazole sodium and genotoxicity, which is applied in the field of detection of potential genotoxic impurities of esomeprazole sodium, can solve the problems of human safety risks, excluding detection of genotoxic impurities, etc., and achieve separation effect Good, improved safety and effectiveness, simple detection conditions

Active Publication Date: 2021-01-15
中玉制药(海口)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0010] The detection and identification method of esomeprazole sodium in the prior art does not include the detection of genotoxic impurities
And in the synthetic route of starting material 2-chloromethyl-3,5-dimethyl-4-methoxypyridine hydrochloride, intermediate 3 (impurity K), 4 (impurity L), 5 (impurity O ) and the nitrogen-oxidized compound (impurity R) on the pyridine ring of 2,3,5-collidine are structural impurities with genotoxicity warnings, and these impurities may be introduced into the raw material drug of esomeprazole sodium There is a potential safety risk to the human body

Method used

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  • Method for detecting potential genotoxic impurities of esomeprazole sodium
  • Method for detecting potential genotoxic impurities of esomeprazole sodium
  • Method for detecting potential genotoxic impurities of esomeprazole sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Choose esomeprazole sodium esomeprazole sodium sample, detect according to the following steps:

[0063] S1. Preparation of mobile phase:

[0064] Take 3.16g of potassium dihydrogen phosphate, add 1000ml of purified water to dissolve, and make phosphate buffer; mix phosphate buffer and acetonitrile at a volume ratio of 63:37, and set aside.

[0065] S2, preparation need testing solution: accurately weigh 0.02g esomeprazole sodium sample to 100ml volumetric flask, dissolve and dilute to scale with mobile phase, as need testing solution, stand-by;

[0066] S3. Accurately weigh an appropriate amount of impurity K, L, O, R reference substance, dissolve and dilute it into a solution containing about 0.05ug of each impurity per 1ml with mobile phase, as the reference substance solution.

[0067] S4, get mixed control solution and need testing solution injection liquid chromatograph respectively, sample size is respectively 20ul, record chromatogram;

[0068] Chromatographic...

Embodiment 2

[0076] The difference between this example and Example 1 lies in that the detection wavelength used in the chromatographic conditions is different, and other detection conditions are consistent with Example 1. In this embodiment, the detection wavelength used: 259 nm.

[0077] The HPLC chromatogram obtained after detection is as follows: figure 2 As shown, the resolution after detection is shown in Table 2.

Embodiment 3

[0079] The difference between this example and Example 1 lies in that the detection wavelength used in the chromatographic conditions is different, and other detection conditions are consistent with Example 1. In this embodiment, the detection wavelength used: 269 nm.

[0080] The HPLC chromatogram obtained after detection is as follows: image 3 As shown, the resolution after detection is shown in Table 2.

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Abstract

The invention discloses a method for detecting potential genotoxic impurities of esomeprazole sodium. The method comprises the following steps: (1) preparing an esomeprazole sodium test sample solution; (2) preparing an impurity control sample solution, the impurity being selected from at least one of 2, 3, 5-trimethylpyridine nitrogen oxide, 2, 3, 5-trimethyl-4-nitropyridine nitrogen oxide, 2, 3,5-trimethyl-4-methoxypyridine nitrogen oxide and 2-chloromethyl-3, 5-dimethyl-4-methoxypyridine nitrogen oxide; (3) detecting the test sample and the control sample by adopting high performance liquid chromatography, and taking a phosphate buffer solution and acetonitrile as mobile phases according to a volume ratio of 58-68: 42-32. According to the method, potential genotoxic impurities in the esomeprazole sodium can be effectively separated and quantitatively detected, conditions are simple, the separation degree is high, and the safety and effectiveness of the esomeprazole sodium can be further improved.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, in particular to a method for detecting potential genotoxic impurities of esomeprazole sodium. Background technique [0002] Esomeprazole Sodium (Esomeprazole Sodium), the chemical name is 5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridyl) Methyl]sulfinyl]-1H-benzimidazole sodium salt. The chemical structural formula of esomeprazole sodium is as shown in the following formula I: [0003] [0004] Esomeprazole sodium is a new generation of proton pump inhibitors. It inhibits the activity of H+ / K+-ATPase, so that H+ in parietal cells cannot be transported into the gastric cavity, thereby reducing the acid content in gastric juice. Because the drug has a strong acid-suppressing effect, it is mostly used clinically for peptic ulcer, refractory gastroesophageal reflux disease, and gastrointestinal bleeding, and the effect is definite. Esomeprazole is less affected by the metabolic enzyme C...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/36G01N30/74G01N30/8679
Inventor 石均平章坛甘杰王春曼
Owner 中玉制药(海口)有限公司
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