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Detection method of salbutamol sulfate-related substances

A technology for salbutamol sulfate and related substances, which is applied in the detection field and can solve the problems of inspection method defects, inability to guarantee the quality and safety of salbutamol sulfate, inability to separate and detect, and the like

Active Publication Date: 2018-10-09
CHENGDU BRILLIANT PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The existing domestic and foreign pharmacopoeias include the detection methods of salbutamol sulfate-related substances, but the inspection methods of the pharmacopoeias have serious defects, and cannot separate and detect all the salbutamol sulfate-related substances, resulting in the inability to guarantee the quality and safety of salbutamol sulfate

Method used

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  • Detection method of salbutamol sulfate-related substances
  • Detection method of salbutamol sulfate-related substances
  • Detection method of salbutamol sulfate-related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Get an appropriate amount of salbutamol sulfate, accurately weighed, add solvent [methanol-water (3:7v / v)] to dissolve and dilute to make a solution containing about 1mg per 1ml, as the test solution; , quantitatively diluted with the above-mentioned solvent to make a solution containing about 5 μg per 1 ml, as a control solution. Measured according to high performance liquid chromatography (Chinese Pharmacopoeia 2015 edition Sibu General Rules 0512), using octylsilane bonded silica gel as filler (Agilent Poroshell 120SB-C8, 4.6×150mm, 2.7 μm), with 0.1% triethylamine- Diammonium hydrogen phosphate buffer solution (take 2.64g of diammonium hydrogen phosphate, add water to dissolve and dilute to 1000ml, add 1ml triethylamine, and adjust the pH value to 3.0 with phosphoric acid) as mobile phase A, methanol as mobile phase B, press Table 1 carries out linear gradient elution; column temperature is 30°C; flow rate is 0.6ml per minute; detection wavelength is 220nm. Take an...

Embodiment 2

[0055] 1 Analytical method establishment

[0056] 1.1 Experimental design and overview

[0057] The synthetic route of salbutamol sulfate (STS) is as follows:

[0058]

[0059] According to the STS synthesis route, it can be seen that the impurities that may appear in the raw materials of this product include starting materials, intermediates, process by-products and degradation products, in which the starting material is S38461, the intermediates are S38901 and S38903, and the process by-products include intermediates The transition state (impurity D and impurity J) that may be produced during the reduction of S38901 and the etherified by-products of S38903 (impurity A, impurity B, S54868, S54879 and impurity F), and the impurities that may be degraded include impurity A, impurity B, S54868, S54879, impurity F and impurity J.

[0060] According to the ability of the synthesis process to remove impurities, the known impurities to be controlled in the intermediate Ⅰ (S3890...

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Abstract

The invention discloses a detection method of salbutamol sulfate-related substances. The detection method qualitatively or quantitatively detects the salbutamol sulfate-related substances with high performance liquid chromatography; detection conditions comprise a chromatographic column: octyl-bonded silica gel column, a detection wavelength: 210-400 nm, and mobile phases comprising a mobile phaseA and a mobile phase B, wherein the mobile phase A is an aqueous phase containing a buffer solution and having pH of 1.5-4.0, further having pH of 2.0-3.0; the mobile phase B mainly comprises methanol or acetonitrile; the mobile phases are eluted by gradient elution; and detection steps are as follows: (1) preparing a test substance solution and a reference substance solution; and (2) respectively sampling and detecting the test solution and the reference solution. The detection method of the salbutamol sulfate-related substances adopted by the invention can ensure effective separation of therelated substances.

Description

technical field [0001] The invention relates to the field of detection methods, in particular to a detection method for salbutamol sulfate related substances. Background technique [0002] Salbutamol sulfate [1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate] is a potent and quick-acting selective β2 receptor agonist for asthmatic bronchitis , bronchial asthma and emphysema patients with bronchospasm and other respiratory diseases have a good therapeutic effect. [0003] The related substances are mainly the starting materials, intermediates, polymers, side reaction products brought in during the production process, and degradation products during the storage process. Research on related substances is one of the key items in drug quality research, and its content not only reflects the direct index of drug purity, but also has important safety significance. The existing domestic and foreign pharmacopoeias include the detection methods of salbutamol sulf...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 晏小雪徐成福陈礼莉吕佩
Owner CHENGDU BRILLIANT PHARMA CO LTD
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