Method for simultaneously measuring plasma concentration of amoxicillin and clavulanate potassium

A technology of potassium amoxicillin-clavulanate and potassium clavulanate, applied in the field of simultaneous determination of blood concentration of potassium amoxicillin-clavulanate, can solve the problems of many interference factors, expensive instruments, low sensitivity, etc., and achieve specificity Strong, simple method, good reproducibility

Inactive Publication Date: 2015-02-11
SICHUAN PHARMA
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Problems solved by technology

[0003] There are microbial methods and HPLC-MS methods for the determination of amoxicillin and clavulanic acid potassium in human plasma. However, although the microbial determination method does not require special equipment, it has low sensitivity and many interference factors, which cannot meet the requirements of amoxicillin and clavulanic acid. Potassium kinetics research and bioequivalence test requirements
HPLC-MS method has high sensitivity, but the instrument is expensive and unstable

Method used

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Examples

Experimental program
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Embodiment 1

[0017] Simultaneously measure the method for amoxicillin-clavulanate potassium blood drug concentration, comprise the following steps:

[0018] (1) Prepare amoxicillin sodium-clavulanate potassium standard stock solution: containing 88.3 micrograms / ml of amoxicillin sodium and 45.3 micrograms / ml of potassium clavulanate;

[0019] (2) Prepare acetaminophen internal standard solution and potassium dihydrogen phosphate buffer;

[0020] (3) Sample pretreatment: Take amoxicillin sodium-clavulanate potassium standard stock solution in a centrifuge tube, add blank plasma to 215 microliters, accurately add 10 microliters of internal standard acetaminophen, vortex for 10 seconds, and then Precisely add 200 microliters of methanol, vortex for 15s, centrifuge at 4000r / min for 6min at 4°C, and take the supernatant for later use;

[0021] (4) Take the supernatant from step (3) and enter the chromatographic column as C18, use acetonitrile-0.05mol / L potassium dihydrogen phosphate buffer 10:...

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PUM

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Abstract

The invention discloses a method for simultaneously measuring the plasma concentration of amoxicillin and clavulanate potassium. The method comprises the steps of depositing proteins of a human plasma sample with methyl alcohol by taking acetaminophen as an interior label, then performing high-speed concentric sample injection, and obtaining the lowest detection concentration of amoxicillin and clavulanate potassium by taking C18 as a chromatographic column and acetonitrile-0.05mmol/L phosphate buffering solution as a flowing phase under the condition that the ultraviolet detection wavelength is 220nm. The method is simple, accurate, sensitive, high in specificity and high in reproducibility and can be used as a plasma concentration measurement method for the biological availability and the bioequivalence study of amoxicillin and clavulanate potassium.

Description

technical field [0001] The invention relates to the field of pharmaceutical production, in particular to a method for simultaneously measuring blood drug concentration of amoxicillin-clavulanate potassium and a preparation method thereof. Background technique [0002] Amoxicillin and Clavulanate Potassium is a compound preparation composed of the β-lactam inhibitor Clavulanate Potassium and the semi-synthetic penicillin Amoxicillin. Amoxicillin is a bactericidal broad-spectrum antibiotic, and potassium clavulanate is an irreversible broad-spectrum β-lactamase inhibitor, which can effectively inhibit the β-lactamase produced by drug-resistant bacteria. Satisfactory curative effect has been achieved clinically. [0003] There are microbial methods and HPLC-MS methods for the determination of amoxicillin and clavulanic acid potassium in human plasma. However, although the microbial determination method does not require special equipment, it has low sensitivity and many interfe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74
Inventor 王强张静文刘萍
Owner SICHUAN PHARMA
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