Rapid, simple, convenient and sensitive detection method for related impurities of glucosamine salt medicines

A technology for glucosamine and related impurities, which is applied in the field of fast, simple and sensitive detection of impurities related to glucosamine salt drugs, can solve the problems of difficult to detect impurities, low sensitivity of thin-layer detection, poor specificity, etc. The effect of strong exclusivity and security

Inactive Publication Date: 2011-11-23
NANJING XIANZHUO BIOLOGICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, our research found that thin layer detection has low sensit

Method used

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  • Rapid, simple, convenient and sensitive detection method for related impurities of glucosamine salt medicines
  • Rapid, simple, convenient and sensitive detection method for related impurities of glucosamine salt medicines
  • Rapid, simple, convenient and sensitive detection method for related impurities of glucosamine salt medicines

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Glucosamine sulfate potassium chloride (provided by Jiangsu Shuanglin Marine Bio-Pharmaceutical Co., Ltd., batch number: 20100425) detection of impurities related to alkali destruction

[0035] Chromatographic conditions and system adaptability test use amino column as detection column; use phosphate buffer (take 0.7gKH 2 PO 4 , add water to dilute to 1000ml, adjust pH to 7.0 with concentrated ammonia solution)-acetonitrile (volume ratio is 35: 65) is mobile phase; Determination wavelength is 195nm. Flow rate: 1.0ml / min; column temperature: 35°C. The number of theoretical plates is not less than 800 based on glucosamine hydrochloride.

[0036]Determination method Take the sample solution neutralized by hydrochloric acid after being destroyed by 1N sodium hydroxide alkali for 30 minutes (glucosamine is unstable under alkaline conditions), dilute it with water to a solution containing about 10 mg per 1 ml, and filter it with a 0.45 μm filter membrane , as the test solu...

Embodiment 2

[0039] Glucosamine hydrochloride (provided by Jiangsu Shuanglin Marine Bio-Pharmaceutical Co., Ltd., batch number: 20100302, the sample is double-packed, lined with polyethylene plastic bags, sealed with aluminum foil, stored in a cool, dry place) related impurities detection solid Samples were stored under high humidity conditions.

[0040] Chromatographic conditions and system adaptability test use amino column as detection column; use phosphate buffer (take 0.7gKH 2 PO 4 , add water to dilute to 1000ml, adjust pH to 7.5 with concentrated ammonia solution)-acetonitrile (volume ratio 35:65) is mobile phase; Determination wavelength is 195nm. Flow rate: 1.0ml / min; column temperature: 35°C. The number of theoretical plates is not less than 800 based on glucosamine hydrochloride.

[0041] Determination method Take an appropriate amount of sample, weigh it accurately, dissolve it in water and make a solution containing about 10 mg per 1 ml, filter it with a 0.45 μm filter memb...

Embodiment 3

[0044] Glucosamine sulfate potassium chloride (provided by Jiangsu Shuanglin Marine Biological Pharmaceutical Co., Ltd., batch number: 20101008, the sample is double-packed, lined with polyethylene plastic bags, sealed with aluminum foil on the outer cover, and stored in a cool, dry place) About impurity detection

[0045] Chromatographic conditions and system adaptability test use amino column as detection column; use phosphate buffer (take 0.7gKH 2 PO 4 , add water to dilute to 1000ml, adjust pH to 7.5 with concentrated ammonia solution)-acetonitrile (volume ratio 35:65) is mobile phase; Determination wavelength is 195nm. Flow rate: 1.0ml / min; column temperature: 35°C. The number of theoretical plates is not less than 800 based on glucosamine hydrochloride.

[0046] Determination method Take an appropriate amount of sample, weigh it accurately, dissolve it in water and make a solution containing about 10 mg per 1 ml, filter it with a 0.45 μm filter membrane, and use it as...

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Abstract

The invention relates to a rapid, simple, convenient and sensitive detection method for related impurities of glucosamine salt medicines, which is characterized in that the detection is performed according to high performance liquid chromatography in pharmacopoeia of the people's republic of China (Edition 2010). A chromatographic condition and system adaptability test comprises the steps of: adopting an amino column as a detection column; preparing a phosphate buffer solution, wherein 0.7 g of KH2PO4 is diluted to 1000 ml by adding water and the pH value is adjusted to be 7.5 by adding a stronger ammonia water solution; adopting the phosphate buffer solution and acetonitrile as a mobile phase, wherein the volume ratio of the phosphate buffer solution to the acetonitrile is 35:65; and detecting wavelength of 195 mm, the flow rate of 1.0 ml/min, the column temperature of 35 DEG C, and the theoretical plate number of not less than 800in the terms of glucosamine hydrochloride . The method overcomes the characteristics of poor sensitivity and poor specificity and the like in the detection by adopting a thin layer detection method in the prior art.

Description

technical field [0001] The invention relates to a method for detecting related impurities in glucosamine salt medicines, in particular to a fast, simple and sensitive detection method for related impurities in glucosamine salt medicines. Background technique [0002] Glucosamine salt drugs (such as glucosamine hydrochloride, glucosamine sulfate sodium chloride and glucosamine sulfate potassium chloride, etc.) are currently a very popular type of bone and joint nutritional supplements in the world, and many countries have approved it as a bone and joint nutritional supplement. Drugs for joint disease. The US FDA included it in the Pharmacopoeia as early as 1995, and the European Union included it in the Pharmacopoeia in 1999. After 1998, my country gradually established the raw materials of glucosamine hydrochloride, glucosamine sulfate sodium chloride and glucosamine sulfate potassium chloride. and its formulation standards. [0003] Glucosamine is a natural amino monosacch...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/60
Inventor 赵利民
Owner NANJING XIANZHUO BIOLOGICAL ENG CO LTD
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