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A kind of detection and separation method of related substances in banbuterol

A technology for related substances and separation methods, which is applied in the field of detection and separation of related substances in bambuterol, can solve the problems of unspecified tert-butylamine residual solvent detection methods, etc., and achieves simple and convenient sample processing, good peak shape and reproducibility, Simple to use effects

Active Publication Date: 2022-07-22
HUNAN JIUDIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, there are no relevant domestic and foreign literature reports on the research on the residual solvent of tert-butylamine in bambuterol, and the quality standards of various countries have not stipulated the detection method of the residual solvent of tert-butylamine. It is necessary to measure the residual solvent of tert-butylamine in bambuterol with high accuracy

Method used

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  • A kind of detection and separation method of related substances in banbuterol
  • A kind of detection and separation method of related substances in banbuterol
  • A kind of detection and separation method of related substances in banbuterol

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Effect test

Embodiment 1

[0050] A method for detecting a related substance in bambuterol, the related substance is tert-butylamine, and the detection instruments and reagents are as follows:

[0051] Reagent: tert-butylamine, purity 99.5%, manufacturer: Aladdin reagent; methanol grade: AR, manufacturer: Sinopharm Group.

[0052] Instrument: gas chromatograph, model 7890B, manufacturer Agilent; electronic analytical balance, model BSA224S-CW, manufacturer: Sartorius.

[0053] The detection and separation method of tert-butylamine in banbuterol is by gas chromatography.

[0054] The gas chromatography conditions were as follows:

[0055] Chromatographic column: DB-1 (30m×0.32mm×3.0μm), inlet temperature: 220℃, detector temperature 240℃, flow rate: 1.2ml / min, injection volume: 1ul, split ratio: 2:1, Carrier gas: nitrogen, heating program: the initial temperature was 40°C, held for 6 minutes, then heated to 180°C at a rate of 20°C / min, held for 2 minutes, and then raised to 200°C at a rate of 30°C / min, ...

Embodiment 2

[0067] A method for detecting a related substance in bambuterol, the related substance is tert-butylamine, and the detection instruments and reagents are as follows:

[0068] Reagent: tert-butylamine, purity 99.5%, manufacturer: Aladdin reagent; methanol grade: AR, manufacturer Sinopharm Group

[0069] Instrument: gas chromatograph, model 7890B, manufacturer Agilent; electronic analytical balance, model BSA224S-CW, manufacturer: Sartorius.

[0070] The detection and separation method of tert-butylamine in banbuterol is by gas chromatography.

[0071] The gas chromatography conditions were as follows:

[0072] Chromatographic column: DB-1 (30m×0.32mm×3.0μm), inlet temperature: 220℃, detector temperature 240℃, flow rate: 0.9ml / min, injection volume: 1ul, split ratio: 6:1, Carrier gas: nitrogen, heating program: the initial temperature was 40 °C, maintained for 6 min, and then heated to 200 °C at a rate of 20 °C / min, maintained for 8 min.

[0073] The specific implementation s...

Embodiment 3

[0084] A method for detecting a related substance in bambuterol, the related substance is tert-butylamine, and the detection instruments and reagents are as follows:

[0085] Reagent: tert-butylamine, purity 99.5%, manufacturer: Aladdin reagent; methanol grade: AR, manufacturer: Sinopharm Group

[0086] Instrument: gas chromatograph, model 7890B, manufacturer Agilent; electronic analytical balance, model BSA224S-CW, manufacturer: Sartorius.

[0087] The detection and separation method of tert-butylamine in banbuterol is by gas chromatography.

[0088] The gas chromatography conditions were as follows:

[0089] Chromatographic column: DB-1 (30m×0.32mm×3.0μm), inlet temperature: 220℃, detector temperature 240℃, flow rate: 0.9ml / min, injection volume: 1ul, split ratio: 6:1, Carrier gas: nitrogen, heating program: the initial temperature was 50°C, held for 6 minutes, then heated to 180°C at a rate of 20°C / min, held for 2 minutes, and then raised to 200°C at a rate of 30°C / min, h...

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Abstract

The invention discloses a method for detecting and separating related substances in bambuterol. The method includes using gas chromatography to detect and separate the related substances in bambuterol, and sets a unique heating program. The invention has simple operation, can effectively detect and separate tert-butylamine in bambuterol, and has the advantages of achieving baseline separation of impurities and adjacent peaks, and good peak shape and reproducibility.

Description

technical field [0001] The invention belongs to the field of drug analysis and detection, and particularly relates to a method for detection and separation of related substances in bambuterol. Background technique [0002] Bambuterol, the chemical name is 5-[2-(tert-butylamino)-1-hydroxyethyl]-1,3-phenylenedidimethylcarbamate, is a long-acting beta 2 receptor agonists. CAS number: 81732-65-2, the structural formula is as follows: [0003] . [0004] It is a new-generation bronchodilator developed by the Swiss Astra Company in 1989 and is one of the main drugs for the treatment of asthma, emphysema and bronchitis. In addition, it can also be used as a smooth muscle relaxant for biliary orifice and biliary sphincter to relieve gallstone colic, gallbladder dyskinesia and morphine addiction. As a bronchial antispasmodic and antiasthmatic drug, it has a long duration of action, very weak side effects, no obvious effect on the heart and digestive system, and has obvious adv...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 陈霞赵梅姣王湘武龚树煌
Owner HUNAN JIUDIAN PHARMA