CN107589212A - A kind of detection method of amoxil capsule about material - Google Patents
A kind of detection method of amoxil capsule about material Download PDFInfo
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- CN107589212A CN107589212A CN201710404599.9A CN201710404599A CN107589212A CN 107589212 A CN107589212 A CN 107589212A CN 201710404599 A CN201710404599 A CN 201710404599A CN 107589212 A CN107589212 A CN 107589212A
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Abstract
A kind of detection method of amoxil capsule about material.Comprise the steps：(1) amoxil capsule sample solution is prepared, the amoxil capsule sample solution includes need testing solution, contrast solution and Amoxicillin system suitability contrast solution；(2) sample solution obtained by step (1) is injected into high performance liquid chromatograph, using mobile phase A：Mobile phase B first carries out isocratic elution, treats linear gradient elution, and record chromatogram immediately after the elution of Amoxicillin peak；(3) according to UV absorption situation, flow velocity 1.0ml/min；Detection wavelength is 254nm；Column temperature：30℃；Sampling volume：20μL.The detection method of the present invention determines the relevant material of amoxil capsule under liquid-phase condition, and detection method is easy to operate, separating degree is high, assay method specificity is strong, testing result is accurately credible.
Description
Technical field
The invention belongs to field of pharmaceutical preparations.Specifically, the present invention relates to a kind of relevant material of amoxil capsule
Detection method.
Background technology
Amoxicillin, also known as amoxicillin or Amoxicillin, it is a kind of the most frequently used semi-synthetic penicillins wide spectrum β-interior
Amide-type antibiotic, it is a kind of white powder, half-life period is about 61.3 minutes, is stablized in acid condition, intestines and stomach absorptivity
Up to 90%, Amoxicillin bactericidal action is strong, and the ability of penetration cell film is also strong, is widely used at present oral semi-synthetic
One of penicillin, its preparation have capsule, tablet, granule, dispersible tablet etc., often share now with clavulanic acid be made it is scattered
Piece.Penicillin anaphylaxis and penicillin skin test positive patient disabling.
The content of the invention
It is an object of the invention to provide a kind of detection method of amoxil capsule about material, detection method of the invention
The relevant material of amoxil capsule is determined under liquid-phase condition, detection method is easy to operate, separating degree is high, assay method is exclusive
Property is strong, testing result is accurately credible.
To achieve the above object, the present invention uses following technical scheme：
A kind of detection method of amoxil capsule about material, this method are carried out using high performance liquid chromatography,
Comprise the steps：
(1) amoxil capsule sample solution is prepared, the amoxil capsule sample solution includes need testing solution, right
According to solution and Amoxicillin system suitability contrast solution；
(2) sample solution obtained by step (1) is injected into high performance liquid chromatograph, using mobile phase A：Mobile phase B is first carried out
Isocratic elution, treat linear gradient elution, and record chromatogram immediately after the elution of Amoxicillin peak；
Mobile phase A：0.05mol/L phosphate buffers：Acetonitrile；
Mobile phase B：0.05mol/L phosphate buffers：Acetonitrile；
The linear gradient elution order of wherein described high performance liquid chromatography is as follows：
(3) according to UV absorption situation, flow velocity 1.0ml/min；Detection wavelength is 254nm；Column temperature：30℃；Sample introduction body
Product：20μL.
Preferably, the preparation method of the need testing solution, contrast solution and Amoxicillin system suitability contrast solution
Comprise the steps：
Amoxil capsule need testing solution：Take the content of this product appropriate, it is accurately weighed, add mobile phase A to dissolve and determine
The solution for containing Amoxicillin (based on C16H19N3O5S) 2.0mg in every 1ml is made in amount dilution, filtration, takes subsequent filtrate to be used as trying
Product solution；
Contrast solution：Take Amoxicillin reference substance appropriate, it is accurately weighed, add mobile phase A to dissolve and quantify dilution and be made often
Containing about 20 μ g solution in 1ml, as contrast solution；
Amoxicillin system suitability contrast solution：Take Amoxicillin system suitability reference substance appropriate, add mobile phase A molten
Solve and dilute and solution in every 1ml containing about 2.0mg is made, as Amoxicillin system suitability contrast solution.
Preferably, the chromatographic column fixed phase filler of the high performance liquid chromatography is octadecylsilane chemically bonded silica.
The detection method of the present invention determines the relevant material of amoxil capsule, the detection method behaviour under liquid-phase condition
Make easy, separating degree height, assay method specificity is strong, testing result is accurately credible.
Embodiment
In order to which the present invention is apparent to understand, with reference to specific embodiment, the invention will be further described, to help
Understand present disclosure.
Embodiment one
A kind of detection method of amoxil capsule about material, this method are carried out using high performance liquid chromatography,
Comprise the steps：
(1) amoxil capsule sample solution is prepared, the amoxil capsule sample solution includes need testing solution, right
According to solution and Amoxicillin system suitability contrast solution, wherein, the need testing solution, contrast solution and Amoxicillin system
The preparation method of applicability contrast solution comprises the steps：
Amoxil capsule need testing solution：Take the content of this product appropriate, it is accurately weighed, add mobile phase A to dissolve and determine
The solution for containing Amoxicillin (based on C16H19N3O5S) 2.0mg in every 1ml is made in amount dilution, filtration, takes subsequent filtrate to be used as trying
Product solution；
Contrast solution：Take Amoxicillin reference substance appropriate, it is accurately weighed, add mobile phase A to dissolve and quantify dilution and be made often
Containing about 20 μ g solution in 1ml, as contrast solution；
Amoxicillin system suitability contrast solution：Take Amoxicillin system suitability reference substance appropriate, add mobile phase A molten
Solve and dilute and solution in every 1ml containing about 2.0mg is made, as Amoxicillin system suitability contrast solution.
The chromatographic column fixed phase filler of the high performance liquid chromatography is octadecylsilane chemically bonded silica.
(2) sample solution obtained by step (1) is injected into high performance liquid chromatograph, using mobile phase A：Mobile phase B (92:8)
Isocratic elution is first carried out, treats linear gradient elution, and record chromatogram immediately after the elution of Amoxicillin peak；
Mobile phase A：0.05mol/L phosphate buffers (take 0.05mol/L potassium dihydrogen phosphates, with 2mol/L hydrogen-oxygens
Change potassium solution and adjust pH value to 5.0)：Acetonitrile (99:1)；
Mobile phase B：0.05mol/L phosphate buffers (pH5.0)：Acetonitrile (80:20)；
The linear gradient elution order of wherein described high performance liquid chromatography is as follows：
(3) according to UV absorption situation, flow velocity 1.0ml/min；Detection wavelength is 254nm；Column temperature：30℃；Sample introduction body
Product：20μL.
General principle, principal character and the advantages of the present invention of the present invention, the technology of the industry has been shown and described above
Personnel under the premise without departing from the spirit and scope of the present invention, can also it will be appreciated that the present invention is not limited to the above embodiments
There are various changes and modifications, these changes and improvement all fall within the protetion scope of the claimed invention.
Claims (3)
1. detection method of a kind of amoxil capsule about material, it is characterised in that this method is to use high performance liquid chromatography
What method was carried out, comprise the steps：
(1) amoxil capsule sample solution is prepared, the amoxil capsule sample solution is molten including need testing solution, control
Liquid and Amoxicillin system suitability contrast solution；
(2) sample solution obtained by step (1) is injected into high performance liquid chromatograph, using mobile phase A：Mobile phase B first carries out isocratic
Elution, treat linear gradient elution, and record chromatogram immediately after the elution of Amoxicillin peak；
Mobile phase A：0.05mol/L phosphate buffers：Acetonitrile；
Mobile phase B：0.05mol/L phosphate buffers：Acetonitrile；
The linear gradient elution order of wherein described high performance liquid chromatography is as follows：
(3) according to UV absorption situation, flow velocity 1.0ml/min；Detection wavelength is 254nm；Column temperature：30℃；Sampling volume：20
μL。
2. according to the method for claim 1, it is characterised in that the need testing solution, contrast solution and Amoxicillin system
The preparation method of system applicability contrast solution comprises the steps：
Amoxil capsule need testing solution：Take the content of this product appropriate, it is accurately weighed, add mobile phase A to dissolve and quantify dilute
The solution for being made and containing Amoxicillin (based on C16H19N3O5S) 2.0mg in every 1ml is released, filtration, takes subsequent filtrate molten as test sample
Liquid；
Contrast solution：Take Amoxicillin reference substance appropriate, it is accurately weighed, add mobile phase A to dissolve and quantify dilution and be made in every 1ml
Containing about 20 μ g solution, as contrast solution；
Amoxicillin system suitability contrast solution：Take Amoxicillin system suitability reference substance appropriate, add mobile phase A dissolving simultaneously
The solution in every 1ml containing about 2.0mg is made in dilution, as Amoxicillin system suitability contrast solution.
3. according to the method for claim 1, it is characterised in that the chromatographic column fixed phase filling of the high performance liquid chromatography
Agent is octadecylsilane chemically bonded silica.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710404599.9A CN107589212A (en) | 2017-06-01 | 2017-06-01 | A kind of detection method of amoxil capsule about material |
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| CN201710404599.9A CN107589212A (en) | 2017-06-01 | 2017-06-01 | A kind of detection method of amoxil capsule about material |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109724934A (en) * | 2019-01-21 | 2019-05-07 | 上海信谊万象药业股份有限公司 | The measuring method of drug content in a kind of Wymox |
| CN109839460A (en) * | 2019-03-14 | 2019-06-04 | 上海海虹实业(集团)巢湖今辰药业有限公司 | A kind of detection method of the Amoxicillin in relation to substance |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050059156A1 (en) * | 2003-08-06 | 2005-03-17 | Pharmacia Italia S.P.A. | Method for detecting contaminants in pharmaceutical products |
| CN101776675A (en) * | 2008-08-27 | 2010-07-14 | 广州联创思远利生物科技有限公司 | Novel detection method of injection use compound amoxicillin sodium and clavulanate potassium |
| CN103713056A (en) * | 2013-11-25 | 2014-04-09 | 宁波出入境检验检疫局检验检疫技术中心 | Method for simultaneously analyzing and detecting residual veterinary drug compositions in animal tissue |
| KR20160091602A (en) * | 2015-01-26 | 2016-08-03 | 대한민국(농림축산식품부 농림축산검역본부장) | Method for rapidly and quantatively analyzing beta-lactam antibiotic resistance and method for evaluating resistance using the same |
-
2017
- 2017-06-01 CN CN201710404599.9A patent/CN107589212A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050059156A1 (en) * | 2003-08-06 | 2005-03-17 | Pharmacia Italia S.P.A. | Method for detecting contaminants in pharmaceutical products |
| CN101776675A (en) * | 2008-08-27 | 2010-07-14 | 广州联创思远利生物科技有限公司 | Novel detection method of injection use compound amoxicillin sodium and clavulanate potassium |
| CN103713056A (en) * | 2013-11-25 | 2014-04-09 | 宁波出入境检验检疫局检验检疫技术中心 | Method for simultaneously analyzing and detecting residual veterinary drug compositions in animal tissue |
| KR20160091602A (en) * | 2015-01-26 | 2016-08-03 | 대한민국(농림축산식품부 농림축산검역본부장) | Method for rapidly and quantatively analyzing beta-lactam antibiotic resistance and method for evaluating resistance using the same |
Non-Patent Citations (1)
| Title |
|---|
| 孟美英: "阿莫西林有关物质研究", 《北方药学》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109724934A (en) * | 2019-01-21 | 2019-05-07 | 上海信谊万象药业股份有限公司 | The measuring method of drug content in a kind of Wymox |
| CN109839460A (en) * | 2019-03-14 | 2019-06-04 | 上海海虹实业(集团)巢湖今辰药业有限公司 | A kind of detection method of the Amoxicillin in relation to substance |
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Application publication date: 20180116 |