Ambroxol hydrochloride detection method

A kind of technology of ambroxol hydrochloride and amino group, which is applied in the field of using high performance liquid chromatography to measure the content of ambroxol hydrochloride and related substances, and can solve the problems of inaccurate content measurement, small content, insufficient measurement sensitivity and the like

Inactive Publication Date: 2010-10-20
云南龙海天然植物药业有限公司
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  • Abstract
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Problems solved by technology

Yet this method is not enough to the determination sensitivity of ambroxol hydrochloride related substance, to the main component trans-4-[6,8-dibromo-1,4-dihydroquinazoline-3(H )] cyclohexanol (impurity B) and 2-amino-3, the determination of the content of 5-dibromobenzaldehyde (impurity A) is inaccurate, and the content of related substances measured is smaller than actual, making the quality of ambroxol Controllability suffers

Method used

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  • Ambroxol hydrochloride detection method
  • Ambroxol hydrochloride detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Embodiment 1 high performance liquid chromatography measures the related substance of ambroxol hydrochloride raw material

[0045] Precision measures about 37.5mg of ambroxol hydrochloride, puts in a 50ml measuring bottle, adds mobile phase and dilutes to the mark, shakes up, as need testing solution. Precisely measure 1ml of the test solution, put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as a control solution; take another trans-4-[6,8-dibromo-1,4-dihydroquinone An appropriate amount of oxazoline-3(H)] cyclohexanol reference substance, accurately weighed, dissolved and diluted with mobile phase to contain 2.25 μg of impurity trans-4-[6,8-dibromo-1,4- Dihydroquinazoline-3(H)]cyclohexanol solution, shake well, as impurity trans-4-[6,8-dibromo-1,4-dihydroquinazoline-3(H)]ring Hexanol (impurity B) reference substance solution; then take an appropriate amount of 2-amino-3,5-dibromobenzaldehyde reference substance, weigh...

Embodiment 2

[0049] Embodiment 2 high performance liquid chromatography is determined the relevant substance of ambroxol hydrochloride injection

[0050] Precision measures Ambroxol Hydrochloride Injection (15mg / 2ml) 5ml, puts in the 50ml measuring bottle, adds mobile phase and is diluted to scale, shakes up, as need testing solution. Precisely measure 1ml of the test solution, put it in a 100ml measuring bottle, add mobile phase to dilute to the mark, shake well, and use it as a control solution; take another trans-4-[6,8-dibromo-1,4-dihydroquinone An appropriate amount of oxazoline-3(H)] cyclohexanol reference substance, accurately weighed, dissolved and diluted with mobile phase to contain 2.25 μg of impurity trans-4-[6,8-dibromo-1,4- Dihydroquinazoline-3(H)]cyclohexanol solution, shake well, as impurity trans-4-[6,8-dibromo-1,4-dihydroquinazoline-3(H)]ring Hexanol reference substance solution; then take an appropriate amount of 2-amino-3,5-dibromobenzaldehyde reference substance, accu...

experiment example 1

[0058] Experimental example 1 adopts method of the present invention and Pharmacopoeia method to quantitatively measure ambroxol related substance comparison

[0059]

[0060] As can be seen from measurement result, adopt method of the present invention, the content of the related substance of measuring is far higher than adopting the content of the related substance of pharmacopoeia method to measure, can better control the quality of ambroxol.

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Abstract

The invention provides a method for measuring ambroxol and related substances trans-4-[6,8-dibromo-1,4-orexin-3(H)] cyclohexanol (impurity B) and 2-amino-3,5-dibromo-benzaldehyde (impurity A) in a preparation of the ambroxol, which is characterized in that: in the measurement of the trans-4-[6,8-dibromo-1,4-orexin-3(H)] cyclohexanol, an adopted detection wavelength is 258 nm and a chromatogram is recorded for a time that is 3 times the retention time of the main component; and the method for measuring the 2-amino-3,5-dibromo-benzaldehyde is characterized in that: the adopted detection wavelength is 238 nm and the chromatogram is recorded for the time that is 3 times the retention time of the main component.

Description

technical field [0001] The invention relates to a detection method of ambroxol hydrochloride, in particular to a method for determining the content of ambroxol hydrochloride and related substances by using high performance liquid chromatography. Background technique [0002] Respiratory system disease is a kind of common disease, frequently-occurring disease, its morbidity rate is all high in the world scope, and has the tendency of increasing, it is the second largest factor of population death in our country. The world's population is currently aging, and the elderly over 65 years of age account for a considerable proportion of deaths due to respiratory diseases. The four symptoms of wheezing, coughing, phlegm, and inflammation are common symptoms of respiratory diseases, and they are mutually causal. Phlegm is the product of respiratory inflammation, which can irritate the respiratory mucosa, cause cough and asthma, and aggravate infection. When patients with acute and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 高春生马璟琪王玉丽刘华
Owner 云南龙海天然植物药业有限公司
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