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Method for detecting p-hydroxyacetophenone related substances

A technology of p-hydroxyacetophenone and hydroxyacetophenone, which is applied in the field of drug analysis and detection, can solve problems such as unrecorded detection methods of hydroxyacetophenone, and achieve the effects of improving drug safety, good reproducibility, and high sensitivity

Active Publication Date: 2021-12-10
河北广祥制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, at present, the pharmacopoeias of various countries have not included the detection methods of related substances of p-hydroxyacetophenone

Method used

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  • Method for detecting p-hydroxyacetophenone related substances
  • Method for detecting p-hydroxyacetophenone related substances
  • Method for detecting p-hydroxyacetophenone related substances

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Embodiment 1

[0035] The embodiment of the present invention provides a method for detecting related substances of p-hydroxyacetophenone

[0036] 1.1 Materials and methods

[0037] Instruments: gas chromatograph, hydrogen flame ionization detector, measuring bottle, electronic balance.

[0038] Blank solvent: 99% methanol and 1% water.

[0039] 1.2 Preparation of solution

[0040] Reference substance solution: Take an appropriate amount of phenol, phenol acetate, 2'-hydroxyacetophenone and 3'-hydroxyacetophenone, weigh them accurately, and make each 1mL reference substance solution with 99% methanol and 1% water Contains 50 μg of phenol, 50 μg of phenol acetate, 50 μg of 2’-hydroxyacetophenone and 50 μg of 3’-hydroxyacetophenone.

[0041] Need testing solution: get p-hydroxyacetophenone need testing appropriate amount, accurately weigh, make every 1mL need testing solution contain p-hydroxyacetophenone need testing 10mg with 99% methanol and 1% water.

[0042] 1.3 Detection method for r...

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Abstract

The invention relates to the technical field of drug analysis and detection, and particularly discloses a method for detecting p-hydroxyacetophenone related substances. According to the method, related substances are determined by adopting a gas chromatographic method, and chromatographic conditions are as follows: a chromatographic column is a capillary column taking phenyl-dimethyl polysiloxane as a stationary liquid; the flow velocity of the carrier gas is 0.5-1.5 ml / min; the split ratio is (8-12): 1; in the heating procedure, the initial temperature is 45-55 DEG C, the temperature is increased to 215-225 DEG C at the speed of 8-12 DEG C per minute, and the temperature is maintained for 5-10 minutes; the temperature of a sample inlet is 240-260 DEG C; a detector is a hydrogen flame ionization detector, and the temperature of the detector is 240-260 DEG C. According to the detection method provided by the invention, effective separation of p-hydroxyacetophenone from 2'-hydroxyacetophenone, 3'-hydroxyacetophenone, phenol and phenol acetate can be realized, and the content of related substances in p-hydroxyacetophenone can be accurately detected. The method disclosed by the invention is sensitive, accurate and relatively good in reproducibility, provides reliable guarantee for improving and better controlling the quality of p-hydroxyacetophenone, and also has very important significance for improving medication safety.

Description

technical field [0001] The invention relates to the technical field of drug analysis and detection, in particular to a detection method for related substances of p-hydroxyacetophenone. Background technique [0002] The name of albuterol sulfate is 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate, and its main function is to selectively excite the β2-receptor on the bronchial smooth muscle to relax the bronchial smooth muscle , so as to relieve bronchial smooth muscle spasm, and have a good therapeutic effect on respiratory diseases such as bronchospasm in patients with asthmatic bronchitis, bronchial asthma and emphysema. [0003] p-Hydroxyacetophenone is an important starting material in the synthesis of salbutamol sulfate. During the synthesis of p-hydroxyacetophenone, related substances of p-hydroxyacetophenone, including isomers of p-hydroxyacetophenone, will inevitably appear 2'-Hydroxyacetophenone and 3'-Hydroxyacetophenone also contain impuritie...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 孙立杰韩倩茹马明卓王亚静毕贺骆会茹尹玉欣荣孜杭刘鹏赵景叶张冠华
Owner 河北广祥制药有限公司
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