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Method for determining content of clenbuterol hydrochloride in ambroxol oral solution

A technology of clenbuterol hydrochloride and oral solution, which is applied in the field of medicinal chemistry, can solve the problems of undurable chromatographic columns and poor specificity, and achieve the effect of simple and convenient method, high accuracy and good specificity

Pending Publication Date: 2022-03-04
北京鑫开元医药科技有限公司
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] The object of the present invention is to provide a kind of method for measuring the content of clenbuterol hydrochloride in the oral solution of ambroterol, to solve the existing method of measuring the content of clenbuterol hydrochloride in the oral solution of ambroterol with HPLC in the prior art Technical problems such as undurable chromatographic columns and poor specificity

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  • Method for determining content of clenbuterol hydrochloride in ambroxol oral solution
  • Method for determining content of clenbuterol hydrochloride in ambroxol oral solution
  • Method for determining content of clenbuterol hydrochloride in ambroxol oral solution

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Embodiment 1

[0067] A method for measuring clenbuterol hydrochloride content in ambroterol oral solution, comprising the steps:

[0068] S1. Preparation of reference substance derivatization solution: Weigh two parts of clenbuterol hydrochloride reference substance, add solvent to dissolve and quantitatively dilute to make a solution containing 1 μg clenbuterol hydrochloride reference substance in each 1mL, measure 10mL respectively Add 5mL of solvent, 1mL of 10% potassium bromide solution and 1mL of 0.3% sodium nitrite solution into different 25mL measuring bottles, shake well, let stand at room temperature for 3 minutes, add 1mL of 1.5% ammonium sulfamate solution, shake every now and then for 10 minutes, then add 1 mL of 0.3% naphthaleneethylenediamine hydrochloride solution, shake well, place in a water bath at 50°C for 10 minutes, let cool, dilute to the mark with a solvent, and shake well to prepare derivatization solutions I and II for reference substances;

[0069] S2. preparation ...

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Abstract

The invention belongs to the technical field of medical chemistry, and provides a method for determining the content of clenbuterol hydrochloride in an ambroxol oral solution. According to the method, a to-be-detected sample is subjected to derivatization treatment and high performance liquid chromatography determination, and the derivatization treatment is that aromatic primary amine groups contained in a clenbuterol hydrochloride structure are diazotized with sodium nitrite in the presence of potassium bromide and then coupled with naphthylethylenediamine to generate the azo compound. The method for determining the content of clenbuterol hydrochloride in the ambroxol oral solution is low in analysis cost, simple and convenient, good in specificity, high in accuracy, good in durability of the chromatographic column and small in harm to human bodies and the environment.

Description

technical field [0001] The invention belongs to the technical field of medicinal chemistry, and more specifically relates to a method for measuring the content of clenbuterol hydrochloride in ambroterol oral solution. Background technique [0002] Ambroxol Oral Solution is a compound preparation composed of ambroxol hydrochloride and clenbuterol hydrochloride, used to treat coughs caused by acute and chronic respiratory diseases (such as acute and chronic bronchitis, bronchial asthma, emphysema, etc.) , Thick sputum, difficulty expectoration, wheezing and other symptoms. Among them, ambroxol hydrochloride is a mucolytic agent, which can increase the secretion of serous glands of the respiratory mucosa, reduce the secretion of mucus glands, reduce the viscosity of sputum, promote the secretion of pulmonary surfactant, increase the movement of bronchial cilia, and make sputum easy to cough up. Clenbuterol hydrochloride is a selective β-receptor agonist, which can relax bronch...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N2030/324Y02P20/55
Inventor 田爱俊曾涛田秋陈戈解亮戴信敏
Owner 北京鑫开元医药科技有限公司
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