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Method for determining content of bipolymer impurities in faropenem sodium

A technology of faropenem sodium and a determination method, applied in the field of drug analysis, can solve the problem of not involving the quantitative detection of faropenem dimer impurities and the like, and achieve the effects of good correlation, strong specificity and good repeatability

Active Publication Date: 2014-11-26
ZHUHAI UNITED LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] CN200910132008.2 discloses a method for determining the content of faropenem polymer impurities in faropenem sodium raw materials and preparations. The method uses dextran gel chromatography to measure the polymers in faropenem sodium raw materials and preparations, and the main component is chromatographed. The peak before the peak is the chromatographic peak of the polymer. Through research, it is found that the chromatographic peak is mainly the ring-opening product of faropenem sodium. This method also does not involve the quantitative detection of faropenem dimer impurities.

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  • Method for determining content of bipolymer impurities in faropenem sodium
  • Method for determining content of bipolymer impurities in faropenem sodium
  • Method for determining content of bipolymer impurities in faropenem sodium

Examples

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Embodiment 1

[0034]Example 1 Preparation of supply solution containing faropenem dimer and confirmation of the dimer

[0035] 1. Instruments and reagents:

[0036] Instruments and reagents: Shimadzu LC-20A high performance liquid chromatography; trifluoroacetic acid, acetonitrile.

[0037] Drugs: Faropenem Sodium DiSesquihydrate, from United Laboratories Co., Ltd.,

[0038] Batch number: 4201304001.

[0039] 2. Experimental method:

[0040] 2.1 Preparation of faropenem sample solution containing dimer: Take about 50 mg of faropenem sodium di-sesquihydrate sample (about 40 mg based on anhydrous faropenem), put it in a 20ml measuring bottle, add trifluorotrifluoroethylene with a volume concentration of 0.05% Aqueous acetic acid was dissolved and diluted to volume, and left overnight at room temperature.

[0041] 2.2 Chromatographic conditions: Shimadzu LC-20A high performance liquid chromatograph is used; specific chromatographic conditions are: chromatographic column: octadecylsilane bo...

Embodiment 2

[0055] Example 2 Detection of Dimer Content in Faropenem Raw Materials

[0056] 1. Instruments and reagents:

[0057] Instruments and reagents: Shimadzu LC-20A high performance liquid chromatography; trifluoroacetic acid, acetonitrile.

[0058] Drugs: Faropenem Sodium DiSesquihydrate, from United Laboratories Co., Ltd.,

[0059] Batch number: 4201304001.

[0060] 2. Detection method

[0061] 2.1 Preparation of faropenem samples containing dimers: take about 1 g of faropenem sodium sesquihydrate samples, place them flat in a flat weighing bottle, add 0.1% trifluoroacetic acid aqueous solution dropwise to moisten , dried in an oven at 60°C, after the dried sample was finely ground, it was then wetted by dripping an aqueous solution of trifluoroacetic acid with a volume concentration of 0.1%, and then dried in an oven at 60°C, and the operation was repeated until the resulting dimer The amount of the substance is obvious enough (the peak area percentage is greater than 0.5%),...

Embodiment 3

[0073] Example 3 Detection of dimers in conventional faropenem raw materials

[0074] 1. Instruments and reagents:

[0075] Instruments and reagents: Shimadzu LC-20A high performance liquid chromatography; trifluoroacetic acid, acetonitrile.

[0076] Drugs: Faropenem Sodium Sesquihydrate Raw Material, from United Laboratories Co., Ltd.

[0077] Batch number: 4201304001.

[0078] 2. Detection method:

[0079] 2.1 Accelerated drug stability test: The raw material of faropenem sodium bis hemihydrate was used for the accelerated stability test. The experimental conditions were: temperature 40°C±2°C, relative humidity 75%±5%, and storage for 6 months.

[0080] 2.2 Preparation of the test solution: Take about 25 mg of the above-mentioned ropenem sodium di-sesquihydrate sample (about 20 mg based on anhydrous faropenem) that has undergone the accelerated stability test, put it in a 10ml measuring bottle, add water to dissolve and dilute to the mark, Shake well, as the test solutio...

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Abstract

The invention relates to the field of pharmacy and provides a method for determining the content of bipolymer impurities in faropenem sodium. The method comprises the following steps: detecting with high performance liquid chromatography under chromatographic conditions that a reversed-phase chromatographic column is an octadecyl silane bonded silica gel column, a mobile phase A is acetonitrile and a mobile phase B is a 0.05% trifluoroacetic acid aqueous solution; and carrying out linear gradient elution. The method is good in correlation, high in sensitivity and good in repeatability, and can be used for quickly judging the content of faropenem bipolymers in faropenem sodium, and therefore, the quality of faropenem sodium can be guaranteed.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a quantitative analysis method for faropenem dimer impurities in faropenem sodium di-sesquihydrate. Background technique [0002] Faropenem sodium two sesquihydrate (hereinafter referred to as "faropenem" or "faropenem sodium" both refer to faropenem sodium two sesquihydrate) is an atypical β-lactam antibiotic, which belongs to the penem class of antibiotics . It has a broad antibacterial spectrum and is particularly effective against anaerobic bacteria, surpassing carbapenem antibiotics. As shown in formula (I), [0003] [0004] This product can inhibit the bacteria caused by Staphylococcus, Streptococcus, Pneumococcus, Enterococcus, Moraxella catarrhalis, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Proteus mirabilis, Haemophilus influenzae, digestive A series of infectious diseases caused by Streptococcus, Propionibacterium acnes, Bacteroides and other moderatel...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 程玉宝刘俊华杜青波赫涡涛傅文强钟雅妮
Owner ZHUHAI UNITED LAB
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