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Method for preparing rabeprazole impurities through HPLC method

A technology of rabeprazole and impurities, applied in the field of organic chemistry and drug synthesis, can solve the problems of long reaction route, unfavorable industrial production, long reaction time, etc., and achieve the effects of short reaction time, mild reaction conditions and high yield

Active Publication Date: 2019-01-04
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The reaction route described in this method is too long, and the reaction time is long, is unfavorable for industrial production

Method used

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  • Method for preparing rabeprazole impurities through HPLC method
  • Method for preparing rabeprazole impurities through HPLC method
  • Method for preparing rabeprazole impurities through HPLC method

Examples

Experimental program
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Embodiment 1

[0030] Step 1: Prepare the reaction solution

[0031] Diluent configuration: Weigh 0.84g of sodium hydroxide, 3.66g of sodium tetraborate decahydrate, add water to 800ml, adjust the pH to 11.3 with 0.1mol / L sodium hydroxide or 0.1mol / L sodium tetraborate solution, add 200ml of acetonitrile , Stir well to obtain the diluted solution.

[0032] Preparation of the reaction solution: Take about 20 mg of rabeprazole raw material, put it in a 100 mL volumetric flask, add 2 mL of 0.2 mol / L hydrochloric acid solution, let it stand for ten minutes, add 2 mL of 0.2 mol / L sodium hydroxide solution for neutralization, and then Add the diluent to the mark to obtain the reaction solution.

[0033] Step 2: Analyze the reaction solution

[0034] The preparation of mobile phase: take by weighing 0.501g ammonium acetate and place in the volumetric flask of 100ml, and add water to the mark, obtain the aqueous solution of 0.065mol / L ammonium acetate, and measure this solution 95ml and mix with 5...

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Abstract

The invention discloses a method for preparing rabeprazole impurities through an HPLC method, and belongs to the fields of organic chemistry and medicine synthesis. The preparation method has the advantages of being simple, convenient to use, short in reaction time, high in target substance purity and helpful to the study of the rabeprazole impurities. The active pharmaceutical ingredient of rabeprazole is taken as the raw material, the HPLC method is adopted to prepare the target impurities, the chemical property of the impurities is analyzed, and bases are provided for the evaluation of thequality, safety and efficiency of the active pharmaceutical ingredient of the rabeprazole.

Description

technical field [0001] The invention belongs to the field of organic chemistry and drug synthesis, in particular to a method for preparing rabeprazole impurity by HPLC. Background technique [0002] Peptic ulcer is a common and frequently occurring digestive system disease, which mainly occurs in the stomach and duodenum, and is a chronic ulcer. Its pathogenesis is related to the imbalance between mucosal injury and protective mechanism. Rabeprazole is a new type of anti-ulcer drug, which belongs to proton pump inhibitors. This type of drug is the latest generation of acid-suppressing drugs currently used clinically, and its acid-suppressing effect is strong and lasting. The proton pump acts on the last link in the process of gastric acid secretion. After being absorbed into the blood in the body, it reaches the secretion tubule of the gastric parietal cell, and is converted into an active substance in an acidic environment, acting on H+-K+-ATPase and inactivating it. As a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/04
CPCC07D401/04
Inventor 黄俊鹏姜春来王赛倾王盼盼祁红林黄肖艳谢斌陈新民
Owner 珠海润都制药股份有限公司
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