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Impurity detection method of amoxicillin bulk drug

A technology of amoxicillin and detection method, which is applied in the field of drug analysis, can solve the problems of inability to improve process conditions, long detection time, low separation degree, etc., and achieve the effect of improved separation effect, convenient operation and simple equipment

Active Publication Date: 2021-03-09
GUANGZHOU LIXIN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] With the development of detection technology and the need to improve the quality of drugs, it is necessary to detect all kinds of impurities caused by process defects relatively completely under the premise that the process conditions cannot be improved. In the past, there were relatively few known types of impurities. The method has limitations, and it is necessary to provide a new detection method to cover as many impurities as possible, while avoiding problems such as low resolution, long detection time, low specificity and poor sensitivity

Method used

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Examples

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Effect test

Embodiment 1

[0027] A method for detecting impurities in amoxicillin raw materials, comprising a liquid chromatographic column with nano-silver hybrid silica gel as a filler, and then using high performance liquid chromatography to detect impurities in amoxicillin raw materials, specifically comprising the following steps :

[0028] The preparation method of the liquid chromatography column using nano-silver hybrid silica gel as filler is:

[0029] S1: Mix nano-silver sol with acidified silica gel matrix, the volume ratio of nano-silver sol and acidified silica gel matrix is ​​1:4, add tert-butyl peroxybenzoate, tert-butyl peroxybenzoate The amount is 5% of the volume of the nano-silver sol mixed with the acidified silica gel matrix, stirred at 75°C for 6 hours, left to stand overnight, and dried by suction;

[0030] S2: Add the product obtained in step S1 to the xylene solution containing octadecyl mercaptan, the amount of the xylene solution is twice the quality of the product obtained ...

Embodiment 2

[0034] A method for detecting impurities in amoxicillin raw materials, comprising a liquid chromatographic column with nano-silver hybrid silica gel as a filler, and then using high performance liquid chromatography to detect impurities in amoxicillin raw materials, specifically comprising the following steps :

[0035] The preparation method of the liquid chromatography column using nano-silver hybrid silica gel as filler is:

[0036] S1: Mix nano-silver sol with acidified silica gel matrix, the volume ratio of nano-silver sol and acidified silica gel matrix is ​​1:5, add tert-butyl peroxybenzoate, tert-butyl peroxybenzoate The amount is 5% of the volume of the nano-silver sol mixed with the acidified silica gel matrix, stirred at 75°C for 6 hours, left to stand overnight, and dried by suction;

[0037] S2: Add the product obtained in step S1 to the xylene solution containing octadecyl mercaptan, the amount of the xylene solution is 4 times the quality of the product obtaine...

Embodiment 3

[0041] A method for detecting impurities in amoxicillin raw materials, comprising a liquid chromatographic column with nano-silver hybrid silica gel as a filler, and then using high performance liquid chromatography to detect impurities in amoxicillin raw materials, specifically comprising the following steps :

[0042] The preparation method of the liquid chromatography column using nano-silver hybrid silica gel as filler is:

[0043] S1: Mix nano-silver sol with acidified silica gel matrix, the volume ratio of nano-silver sol and acidified silica gel matrix is ​​1:5, add tert-butyl peroxybenzoate, tert-butyl peroxybenzoate The amount is 5% of the volume of the nano-silver sol mixed with the acidified silica gel matrix, stirred at 75°C for 6 hours, left to stand overnight, and dried by suction;

[0044] S2: Add the product obtained in step S1 to the xylene solution containing octadecyl mercaptan, the amount of the xylene solution is 3 times the quality of the product obtaine...

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Abstract

The invention belongs to the field of pharmaceutical analysis, and particularly relates to a method for separating impurities from an amoxicillin bulk drug by adopting a liquid chromatographic columnobtained by nano-silver hybrid silica gel filler. The method provided by the invention comprises the following steps of: preparing a liquid chromatographic column taking nano-silver hybrid silica gelas a filler, and then performing detection by adopting high performance liquid chromatography. The preparation method of the nano-silver hybrid silica gel comprises the following steps: mixing an acidified silica gel matrix and nano-silver sol, and enabling the mixture to react with octadecyl mercaptan to obtain the nano-silver hybrid silica gel. The chromatographic conditions are as follows: theused mobile phase consists of a mobile phase A and a mobile phase B, the mobile phase A is a solution prepared from tetrabutylammonium iodide, glacial acetic acid and water, the mobile phase B is a mixed solution of methanol and water, and the mobile phase A and the mobile phase B are mixed and then subjected to ultrasonic treatment for 5-30 minutes. Compared with a traditional detection method, the novel chromatographic column obtained by the invention is high in analysis effect, relatively high in column efficiency and separation degree and relatively short in analysis time, and is particularly suitable for quality monitoring of amoxicillin bulk drugs.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to the application of a liquid chromatography column obtained by a nano-silver hybrid silica gel filler in separating impurities of amoxicillin bulk medicine. Background technique [0002] Amoxicillin is one of the most commonly used semi-synthetic penicillin broad-spectrum β-lactam antibiotics. It is a white powder. Amoxicillin has strong bactericidal effect and is one of the broad-spectrum penicillins widely used at present. [0003] During the whole process of preparation of amoxicillin API, a certain amount of impurities will be produced due to the limitation of process conditions. The impurities disclosed now include: impurity A, impurity B, impurity C, impurity D, impurity E, impurity F, and impurity G , Impurity H, Impurity I, Impurity J, Impurity K, Impurity L, Impurity M [0004] [0005] [0006] Based on the special physical and chemical properties of nanom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675
Inventor 高悦译
Owner GUANGZHOU LIXIN PHARM CO LTD
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