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Method for detecting impurities in amoxicillin granules

A technology of amoxicillin and detection method, which is applied in the field of drug analysis, can solve the problems of few impurities, impurities that cannot be effectively separated, and cannot be separated at the same time, so as to ensure the quality of drugs, improve the separation effect of the system, and achieve good results in sensitivity and repeatability

Active Publication Date: 2021-01-12
GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0014] However, the above detection method has few impurities that can be separated, and some impurities are not completely separated from the solvent peak.
[0015] To sum up, in the previous investigation on the separation effect of amoxicillin particle impurities in various mobile phase systems, it was found that some impurities could not be effectively separated, that is, these methods could not simultaneously separate the above-mentioned 12 known impurities of amoxicillin

Method used

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  • Method for detecting impurities in amoxicillin granules
  • Method for detecting impurities in amoxicillin granules
  • Method for detecting impurities in amoxicillin granules

Examples

Experimental program
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Effect test

Embodiment 1

[0033] Embodiment one: amoxicillin particle analysis method one

[0034] Mobile phase A: ion-pair buffer (containing 0.05mol / L potassium dihydrogen phosphate, 0.01% tetrabutylammonium hydroxide (V / V), adjusting pH to 5.0 with phosphoric acid): acetonitrile 99:1

[0035] Mobile phase B: Ion-pair buffer (containing 0.05mol / L potassium dihydrogen phosphate, 0.01% tetrabutylammonium hydroxide (V / V), adjusting pH to 5.0 with phosphoric acid): acetonitrile 80:20

[0036] Column temperature: 25°C

[0037] Gradient elution: firstly use mobile phase A-mobile phase B (92:8) for isocratic elution, after the amoxicillin peak is eluted, follow the gradient elution procedure as follows: 0-35min, mobile phase A: mobile phase B volume ratio gradually becomes 0:100, gradient elution; 35-45min, mobile phase A: mobile phase B volume ratio is 0:100, isocratic elution; 45-46min, mobile phase A: mobile phase B volume ratio gradually changes 92:8, gradient elution; 46min later, mobile phase A: mob...

Embodiment 2

[0038] Embodiment two: amoxicillin particle analysis method two

[0039] Mobile phase A: ion-pair buffer (containing 0.05mol / L potassium dihydrogen phosphate, 0.1% tetrabutylammonium hydroxide (V / V), adjusting pH to 5.0 with phosphoric acid): acetonitrile 99:1

[0040] Mobile phase B: Ion pair buffer (containing 0.05mol / L potassium dihydrogen phosphate, 0.1% tetrabutylammonium hydroxide, adjusted pH to 5.0 with phosphoric acid): acetonitrile 80:20

[0041] Column temperature: 28°C

[0042] Gradient elution is the same as in Example 1.

Embodiment 3

[0043] Embodiment three: amoxicillin particle analysis method three

[0044] Mobile phase A: Ion-pair buffer (containing 0.05mol / L potassium dihydrogen phosphate, 0.5% tetrabutylammonium hydroxide (V / V), adjusting pH to 5.0 with phosphoric acid): acetonitrile 99:1

[0045] Mobile phase B: ion-pair buffer (containing 0.05mol / L potassium dihydrogen phosphate, 0.5% tetrabutylammonium hydroxide (V / V), adjusting pH to 5.0 with phosphoric acid): acetonitrile 80:20

[0046] Column temperature: 30°C

[0047] Gradient elution is the same as in Example 1.

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Abstract

The invention provides a method for detecting impurities in amoxicillin particles. The method is an HPLC (high performance liquid chromatography) detection method. According to the HPLC detection method, both a flowing phase A and a flowing phase B contain tetrabutyl ammonium hydroxide, and the impurities A, B, C, D, E, F, G, H, I, J and M in amoxicillin particles can be simultaneously detected. After the tetrabutyl ammonium hydroxide is added, the separation effect of a flowing phase system is enhanced, the impurities which cannot be effectively separated by a common analysis method can be separated by the method, and the separation effect of the system is improved. The analysis method has very important application values in quality control of the amoxicillin particles, and the drug quality of the amoxicillin particles can be effectively ensured.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a method for detecting impurities in amoxicillin granules. Background technique [0002] Amoxicillin is recommended by WHO as the first choice of β-lactam oral antibiotics. It has a strong bactericidal effect and a strong ability to penetrate the cell membrane. It has a strong killing effect on both Gram-negative bacteria and Gram-positive bacteria. It is widely used clinically in the treatment of respiratory system, urinary system, digestive system, ENT, obstetrics and gynecology, sexually transmitted diseases, dermatology and other infections. When amoxicillin is used as a medicine, the content is required to be no less than 98.5%, and the content of impurities is strictly limited. [0003] The currently known impurities of amoxicillin are A, B, C, D, E, F, G, H, I, J, L, M, which come from synthetic raw materials, resolution reagents, intermediates and degradation products. The s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88
CPCG01N30/88
Inventor 李翠芬王玮邢盛王健松裴泽健
Owner GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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