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Impurity detection method of cefozopran hydrochloride

A technology for the detection of cefozopran hydrochloride and its detection method, which is applied in the field of impurity detection of cefozopran hydrochloride, can solve problems such as poor peak shape and detection of impurity content, and achieve good separation effect

Pending Publication Date: 2021-10-26
HAINAN HAILING CHEMIPHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Although it claims that the main degradation products and the main drug of each damaged sample can be effectively separated, and the method has good specificity, it is obvious from the chromatogram that some chromatographic peaks overlap each other, especially the overlap of impurity peaks in the oxidative damaged samples , the peak shape is poor, therefore, its method cannot perform reasonable and accurate detection of impurity content for damaged samples with a lot of impurity content

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  • Impurity detection method of cefozopran hydrochloride
  • Impurity detection method of cefozopran hydrochloride
  • Impurity detection method of cefozopran hydrochloride

Examples

Experimental program
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Effect test

Embodiment 1

[0018] Embodiment 1-cefazolam hydrochloride impurity detection chromatographic conditions:

[0019] Instrument: Shimadzu liquid chromatograph

[0020] Chromatographic column: ACE Excel CN-ES chromatographic column (50mm×3.0mm, 5μm) is connected in series with Waters Atlantis T3 C18 chromatographic column (150mm×4.6mm, 3μm);

[0021] Mobile phase: with methanol and acetonitrile volume ratio 30:70 as mobile phase A, with a mass concentration of 0.5% triethylamine aqueous solution as mobile phase B and mobile phase B with glacial acetic acid to adjust the pH to 4.50; mobile phase A and mobile phase B The volume ratio is 40:60.

[0022] Flow rate 1.5 mL / min.

[0023] The detection wavelength is 254nm.

[0024] The column temperature is 25°C.

Embodiment 2

[0025] Embodiment 2-cefazolam hydrochloride impurity detection chromatographic conditions:

[0026] Instrument: Shimadzu liquid chromatograph

[0027] Chromatographic column: ACE Excel CN-ES chromatographic column (50mm×3.0mm, 5μm) is connected in series with Waters Atlantis T3 C18 chromatographic column (150mm×4.6mm, 3μm);

[0028] Mobile phase: with methanol and acetonitrile volume ratio 20:80 as mobile phase A, with a mass concentration of 0.5% triethylamine aqueous solution as mobile phase B and mobile phase B with glacial acetic acid to adjust the pH to 4.50; mobile phase A and mobile phase B The volume ratio is 20:80.

[0029] Flow rate 1.5 mL / min.

[0030] The detection wavelength is 254nm.

[0031] The column temperature is 25°C.

Embodiment 3

[0032] Embodiment 3-cefazolam hydrochloride impurity detection chromatographic conditions:

[0033] Instrument: Shimadzu liquid chromatograph

[0034] Chromatographic column: ACE Excel CN-ES chromatographic column (50mm×3.0mm, 5μm) is connected in series with Waters Atlantis T3 C18 chromatographic column (150mm×4.6mm, 3μm);

[0035] Mobile phase: with methanol and acetonitrile volume ratio 30:70 as mobile phase A, with a mass concentration of 0.5% triethylamine aqueous solution as mobile phase B and mobile phase B to adjust pH to 3.40 with glacial acetic acid; mobile phase A and mobile phase B The volume ratio is 40:60.

[0036] Flow rate 1.5 mL / min.

[0037] The detection wavelength is 254nm.

[0038] The column temperature is 25°C.

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Abstract

The invention discloses an impurity detection method of cefozopran hydrochloride. Chromatographic conditions are as follows: an ACE Excel CN-ES chromatographic column and a Waters Atlants T3C18 chromatographic column are connected in series; methanol and acetonitrile in a volume ratio of (20-30): (70-80) are taken as a mobile phase A, and a triethylamine aqueous solution with a mass concentration of 0.3-0.5% is taken as a mobile phase B; and the volume ratio of the mobile phase A to the mobile phase B is (20-40): (60-80). By adopting the method provided by the invention, the separation degree of each peak of the cefozopran hydrochloride bulk drug is good, the separation degree is greater than 1.5, and the tailing factor is 0.8-1.2. The method is also suitable for detection of various damaged samples with more impurities, and is more beneficial to quality monitoring of cefozopran hydrochloride.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a method for detecting impurities of cefozopram hydrochloride. Background technique [0002] Cefozopran hydrochloride, also known as cefozopran hydrochloride, chemical name: [[(6R,7R)-7-[(Z)-2-(5-amino-1,2,4-thia Oxadiazol-3-yl)-2-methoxyiminoacetamido]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-3- Base]methyl]imidazo[1,2-b]pyridazinium hydroxide inner salt monohydrochloride. It is a fourth-generation cephalosporin, a semi-synthetic, parenteral cephalosporin, with a wider antibacterial spectrum, effective against Gram-negative bacteria, Gram-positive bacteria, and Pseudomonas aeruginosa. Sepsis, wound infection, and various infections caused by Gram-positive bacteria, Gram-negative bacteria, etc. [0003] To the best of our knowledge, there are few reports on impurity detection methods for cefozopran hydrochloride. Known relevant literature has " H...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02Y02A50/30
Inventor 路国荣陆一峰韩勇
Owner HAINAN HAILING CHEMIPHARMA CORP
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