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Method for detecting amoxicillin and clavulanate potassium polymer for injection

A technique for the detection of amoxicillin-clavulanate potassium and its detection method, which is applied in the detection field of amoxicillin-clavulanate potassium polymer for injection, can solve the problems of low accuracy and low specificity, and achieve strong accuracy and specificity , the effect of simple operation

Inactive Publication Date: 2021-03-16
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In order to overcome the problems of low specificity and low accuracy of polymer detection methods in existing amoxicillin-clavulanate potassium compound preparations, the invention provides a method for detection of amoxicillin-clavulanate potassium polymers for injection. Can accurately determine impurity A, impurity B, amoxicillin impurity C, amoxicillin impurity D, amoxicillin impurity J and amoxicillin ring-closed trimer;

Method used

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  • Method for detecting amoxicillin and clavulanate potassium polymer for injection
  • Method for detecting amoxicillin and clavulanate potassium polymer for injection
  • Method for detecting amoxicillin and clavulanate potassium polymer for injection

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Embodiment 1

[0052] Such as Figure 1-26 Shown, a kind of polymer detection method of amoxicillin clavulanate potassium for injection comprises the steps:

[0053] (1) Reagents: Acetonitrile (chromatographically pure), potassium dihydrogen phosphate (analytical pure), sodium hydroxide (analytical pure), amoxicillin and clavulanic acid system suitability reference substances.

[0054] (2) Equipment: analytical balance (sensitivity above 0.1mg), high performance liquid chromatography, pipette (1mL), volumetric flask (100mL, 20mL, 2mL), chromatographic column (octadecylsilane bonded silica gel as a filler).

[0055] (3) Sample preparation

[0056] Need testing solution is made by following method: get amoxicillin clavulanate potassium 50mg, accurately weighed, is placed in 20mL volumetric flask, adds deionized water to dissolve and is diluted to scale, shakes up, as need testing solution;

[0057]Contrast solution is made by following method: precision measures need testing solution 1mL, i...

Embodiment 2

[0072] A method for detecting amoxicillin-clavulanate potassium polymer for injection, comprising the steps of:

[0073] (1) Reagents and drugs: acetonitrile (chromatographically pure), potassium dihydrogen phosphate (analytical pure), sodium hydroxide (analytical pure), amoxicillin and clavulanic acid system suitability reference substances.

[0074] (2) Equipment: analytical balance (sensitivity above 0.1mg), high performance liquid chromatography, pipette (1mL), volumetric flask (100mL, 20mL, 2mL), chromatographic column (octadecylsilane bonded silica gel as a filler).

[0075] (3) Sample preparation

[0076] Need testing solution is made by following method: get amoxicillin clavulanate potassium 50mg, accurately weighed, is placed in 20mL volumetric flask, adds deionized water to dissolve and is diluted to scale, shakes up, as need testing solution;

[0077] Contrast solution is made by following method: precision measures need testing solution 1mL, is placed in 100mL vo...

Embodiment 3

[0090] A method for detecting amoxicillin-clavulanate potassium polymer for injection, comprising the steps of:

[0091] (1) Reagents and drugs: acetonitrile (chromatographically pure), potassium dihydrogen phosphate (analytical pure), sodium hydroxide (analytical pure), amoxicillin and clavulanic acid system suitability reference substances.

[0092] (2) Equipment: analytical balance (sensitivity above 0.1mg), high performance liquid chromatography, pipette (1mL), volumetric flask (100mL, 20mL, 2mL), chromatographic column (octadecylsilane bonded silica gel as a filler).

[0093] (3) Sample preparation

[0094] Need testing solution is made by following method: get amoxicillin clavulanate potassium 50mg, accurately weighed, is placed in 20ml volumetric flask, adds deionized water to dissolve and is diluted to scale, shakes up, as need testing solution;

[0095] Contrast solution is made by following method: precision measures need testing solution 1mL, is placed in 100mL vo...

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Abstract

The invention discloses a method for detecting an amoxicillin potassium clavulanate polymer for injection. The method can accurately determine an impurity A, an impurity B, an amoxicillin impurity C,an amoxicillin impurity D, an amoxicillin impurity J and an amoxicillin closed-loop trimer. The method comprises the following steps: (1) reagent test: acetonitrile (chromatographically pure), monopotassium phosphate (analytically pure), sodium hydroxide (analytically pure) and amoxicillin and clavulanic acid system applicability reference substances; (2) instrument equipment; (3) preparing a sample; (4) a chromatographic condition chromatographic method: a high performance liquid chromatography method; octadecylsilane chemically bonded silica is used as a filler of a chromatographic column; the detection wavelength is 230 nm; the sample size is 20 [mu] L; the flow rate is 1.0 mL / min; the column temperature is 30 DEG C; (5) measuring 20 [mu] L of the system suitability solution in a systemsuitability test, injecting the system suitability solution into a liquid chromatograph, and ensuring that the separation degree between chromatographic peaks meets the requirements (greater than orequal to 1.5); and (6) mass spectrum detection and analysis.

Description

technical field [0001] The invention belongs to the field of drug impurity analysis and detection, in particular to a method for detection of amoxicillin-clavulanate potassium polymer for injection. Background technique [0002] Polymers in β-lactam antibiotics are important allergens that induce allergic reactions. In order to ensure the safety of drugs, the Chinese Pharmacopoeia strictly controls them. Potassium amoxicillin and clavulanate is an amoxicillin compound preparation containing enzyme inhibitors widely used clinically, and sometimes there are adverse reports of it inducing allergic reactions in clinical practice, so the control of polymers in such compound preparations is becoming more and more important. more attention. The Chinese Pharmacopoeia 2015 edition, the British Pharmacopoeia (BP 2016), and the United States Pharmacopoeia (USP39) all recorded the compound preparation of amoxicillin and clavulanate potassium. The 2015 edition of the Chinese Pharmacopo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 马莉李珠珠史权杰
Owner HAINAN WEI KANG PHARMA QIANSHAN