Method of simultanaously detecting racemic methylephedrine hydrochloride, hydrobromic acid youmeishafen and clofenetamine maleate composition

A technology for racemic methylephedrine hydrochloride and chlorpheniramine maleate compositions, which is applied in the field of simultaneous detection of racemic methylephedrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate compositions, It can solve the problems of poor precision, accuracy and reproducibility, not suitable for drug quality control, long equilibration time, etc., and achieve the effect of good reproducibility, strong practicability and good recovery rate

Active Publication Date: 2011-02-16
JIANGZHONG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The determination of content in racemic methylephedrine hydrochloride (JP13) drug standard and dextromethorphan hydrobromide drug standard adopts volumetric analysis method, and "Chinese Pharmacopoeia" 2005 edition two chlorpheniramine maleate content determination adopts volumetric analysis The content determination of chlorpheniramine maleate tablets adopts ultraviolet spectrophotometry, and the volumetric analysis method in the compound preparation needs to extract each component medicine respectively from the preparation, and then measure the content of each component respectively with the method of volumetric analysis titration. content, the method is complicated, the operation is cumbersome and time-consuming, the precision, accuracy and reproducibility are poor, and it takes nearly a week to measure once, and the practicability is poor
The content of each component is determined separately by ultraviolet spectrophotometry, and the sample pretreatment is very cumbersome and the reproducibility is also poor; there is no method to measure the content of the three drugs simultaneously under the same chromatographic condition by applying high performance liquid chromatography, and Different mobile phases and different column temperature conditions need to be used. When switching between different measurement conditions, the equilibration time is too long, which is not suitable for drug quality control

Method used

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  • Method of simultanaously detecting racemic methylephedrine hydrochloride, hydrobromic acid youmeishafen and clofenetamine maleate composition
  • Method of simultanaously detecting racemic methylephedrine hydrochloride, hydrobromic acid youmeishafen and clofenetamine maleate composition

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Experimental program
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Effect test

Embodiment 1

[0021] Use octadecylsilane bonded silica gel as filler; use methanol-acetonitrile-water-tetrahydrofuran (180:420:350:50), add 4.45g sodium dioctyl sulfosuccinate per 1000ml, adjust with phosphoric acid The pH value to 5.0 is the mobile phase, and the detection wavelength is 258nm. Take 15 grams of this product (containing about 50 mg of racemic methylephedrine hydrochloride, 40 mg of dextromethorphan hydrobromide, and 6.25 mg of chlorpheniramine maleate) in a 250 ml measuring bottle, add mobile phase for ultrasonic dissolution, and let cool until At room temperature, dilute to the mark with mobile phase, shake well, filter, accurately measure 20 μ l of the subsequent filtrate, inject it into the liquid chromatograph, and record the chromatogram; In the measuring bottle, add mobile phase to dissolve and dilute to the scale, as chlorpheniramine maleate reference substance stock solution; cancel methylephedrine hydrochloride reference substance 20mg, dextromethorphan hydrobromide...

Embodiment 2

[0023] Use octadecylsilane bonded silica gel as filler; use ethanol-acetonitrile-water-tetrahydrofuran (150:450:370:30), add 5.0 g of sodium dioctyl sulfosuccinate per 1000 ml, adjust with acetic acid The pH value to 5.0 is the mobile phase, and the detection wavelength is 258nm. Take 15 grams of this product (containing about 50 mg of racemic methylephedrine hydrochloride, 40 mg of dextromethorphan hydrobromide, and 6.25 mg of chlorpheniramine maleate) in a 250 ml measuring bottle, add mobile phase for ultrasonic dissolution, and let cool until At room temperature, dilute to the mark with mobile phase, shake well, filter, accurately measure 20 μ l of the subsequent filtrate, inject it into the liquid chromatograph, and record the chromatogram; In the measuring bottle, add mobile phase to dissolve and dilute to the scale, as chlorpheniramine maleate reference substance stock solution; cancel methylephedrine hydrochloride reference substance 20mg, dextromethorphan hydrobromide ...

Embodiment 3

[0025] Use octadecylsilane bonded silica gel as a filler; use methanol-acetonitrile-water-tetrahydrofuran (200:400:330:70), add 3.5g sodium dioctyl sulfosuccinate per 1000ml, adjust with phosphoric acid The pH value to 5.0 is the mobile phase, and the detection wavelength is 258nm. Take 15 grams of this product (containing about 50 mg of racemic methylephedrine hydrochloride, 40 mg of dextromethorphan hydrobromide, and 6.25 mg of chlorpheniramine maleate) in a 250 ml measuring bottle, add mobile phase for ultrasonic dissolution, and let cool until At room temperature, dilute to the mark with mobile phase, shake well, filter, accurately measure 20 μ l of the subsequent filtrate, inject it into the liquid chromatograph, and record the chromatogram; In the measuring bottle, add mobile phase to dissolve and dilute to the scale, as chlorpheniramine maleate reference substance stock solution; cancel methylephedrine hydrochloride reference substance 20mg, dextromethorphan hydrobromid...

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Abstract

A method for simultaneously detecting compositions of despun methylphedrine hydrochloride, hydrobromic acid dexmethaphen and maleic acid chlorpheniramine in compound includes applying high efficient liquid-phase chromatography; using octadecyl silane linkage silica gel as filler; using mixed solvent of methanol, acetonitrile, water and tetrahydrofuran as mobile phase; adding sulfosodium auccinatedicaprylate; using acid to regulate pH value; feeding in sample once to detect three compositions simultaneously.

Description

technical field [0001] The present invention is a method capable of simultaneously detecting three main active ingredients racemic methylephedrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate composition contained in anti-cold medicine, specifically High-performance liquid chromatography is used for the determination of component identification, content and related substances. Background technique [0002] Influenza is a kind of common disease of respiratory system, frequently-occurring disease, and clinical manifestation is main symptom with headache, nasal congestion, runny nose, nauseating, heating. The cold medicine of the present invention is a compound preparation, which contains active main ingredients of racemic methylephedrine hydrochloride, dextromethorphan hydrobromide and chlorpheniramine maleate, and also contains acetaminophen and vitamin C for antipyretic Analgesic, antitussive, relieve runny nose, nasa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/60G01N30/26B01J20/281
Inventor 孙萍余银芳喻萍卢建中易敏之
Owner JIANGZHONG PHARMA
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