Avibactam sodium optical isomer high performance liquid chromatography detection method

A technology of high-performance liquid chromatography and optical isomers, which is applied in the field of high-performance liquid chromatography detection of optical isomers of avibactam sodium, to achieve the effects of ensuring clinical effects, accurate detection, and good specificity

Active Publication Date: 2018-08-03
珠海优润医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

There is currently no method for the analysis and detection of optical isomers of avibactam sodium

Method used

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  • Avibactam sodium optical isomer high performance liquid chromatography detection method
  • Avibactam sodium optical isomer high performance liquid chromatography detection method
  • Avibactam sodium optical isomer high performance liquid chromatography detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 Separation degree experiment, sample test and sample addition experiment

[0026] Instruments and reagents: Shimadzu 2030C 3D high performance liquid chromatography; ethanol is chromatography grade, trifluoroacetic acid and diethylamine are analytical grade.

[0027] Sample: avibactam sodium, its enantiomer (2R, 5S) avibactam sodium and 2 diastereomers.

[0028] experimental method:

[0029] Chromatographic conditions: Daicel IC column (250*4.6mm 5um); ethanol: diethylamine: trifluoroacetic acid (100:0.15:0.1) as mobile phase, flow rate 1.0ml / min; column temperature 30°C; detector It is an ultraviolet detector with a detection wavelength of 210nm.

[0030] Separation degree test: Take about 10 mg of avibactam sodium and its enantiomer (2R, 5S) avibactam sodium respectively, add 20 ml of ethanol to dissolve, take 10 μl and inject into the liquid chromatograph, the chromatogram is as follows figure 1 shown.

[0031] Sample test experiment: take about 20mg...

Embodiment 2

[0035] The influence of embodiment 2 column temperature on separation

[0036] Instruments and reagents: Shimadzu 2030C 3D high performance liquid chromatography; ethanol is chromatography grade, trifluoroacetic acid and diethylamine are analytical grade.

[0037] Sample: avibactam sodium, enantiomer (2R, 5S) avibactam sodium and 2 diastereomers.

[0038] experimental method:

[0039] Chromatographic condition 1: Daicel IC column (250*4.6mm 5um); ethanol: diethylamine: trifluoroacetic acid (100:0.15:0.1) as mobile phase, flow rate 1.0ml / min; column temperature 40°C; detection The wavelength is 210nm.

[0040] Chromatographic condition 2: Daicel IC column (250*4.6mm 5um); ethanol: diethylamine: trifluoroacetic acid (100:0.15:0.1) as mobile phase, flow rate 1.0ml / min; column temperature 25°C; detection The wavelength is 210nm.

[0041] Sample test experiment: take about 20mg of actually produced avibactam sodium, add 20ml of ethanol to dissolve.

[0042] Sample adding isome...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis detection, and more specifically relates to an avibactam sodium optical isomer high performance liquid chromatography detectionmethod. According to the invention, a celluloid IC column is taken as a chromatographic column, a mobile phase is a mixture of ethanol, diethylamine and trifluoroacetic acid with the volume ratio being 100: 0.15: 0.1, the column temperature is 25-40 DEG C, the flow velocity is 1ml/min, and the detection wavelength is 210 nm. The avibactam sodium optical isomer high performance liquid chromatography detection method has the advantages of good specialization, sensitivity and reappearance, can accurately detect the content of an optical isomer in avibactam sodium, and can guarantee good clinicaleffect.

Description

technical field [0001] The invention belongs to the technical field of drug analysis and detection, in particular to a high-performance liquid chromatography detection method for optical isomers of avibactam sodium. Background technique [0002] Avibactam sodium (avibactam sodium), chemical name: [(2S,5R)-2-amido-7-oxyl-1,6-diazabicyclo[3.2.1]octane-6-yl ] Sodium sulfonate, structural formula It is a new type of β-lactamase inhibitor. The mechanism of action of avibactam is substantially different from that of the classical β-lactamase inhibitors (sulbactam, tazobactam, clavulanic acid). In the process of inhibiting β-lactamases, the structure of avibactam itself can be restored by the reverse reaction, so it has long-term enzyme inhibitory effect. Avibactam itself has no obvious antibacterial activity, but the clinical effect is better when used in combination with ceftaroline, ceftazidime, and aztreonam. [0003] In the structure of avibactam sodium, there are two chi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/74
CPCG01N30/02G01N30/34G01N30/74
Inventor 柯兴斌左斌海赵红升张勇付长安
Owner 珠海优润医药科技有限公司
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