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Process for preparing comparison solution for measuring polymeric substance in Cefepime, its salt raw material and preparation

A technology of reference substance solution and cefepime, which is applied in measuring devices, material separation, and analysis of materials, can solve problems such as poor reproducibility, small association peaks, and large association peaks to achieve reproducibility Good, stable peak area, and stable associations

Active Publication Date: 2008-09-03
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

We refer to the preparation method of the above-mentioned cephalosporin variety polymer reference substance solution recorded in the Chinese Pharmacopoeia 2000 edition, adopt the cefepime polymer reference substance solution prepared by dissolving the cefepime reference substance in water, cefepime can not be completely associated, and its The association peak is very small, followed by a large cefepime steamed bread peak, and the steamed bread peak slowly becomes smaller as the storage time prolongs, and the association peak slowly becomes larger, resulting in poor reproducibility of the determination, let alone Quantitative analysis causes great difficulty in determination and inaccurate measurement data

Method used

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  • Process for preparing comparison solution for measuring polymeric substance in Cefepime, its salt raw material and preparation
  • Process for preparing comparison solution for measuring polymeric substance in Cefepime, its salt raw material and preparation
  • Process for preparing comparison solution for measuring polymeric substance in Cefepime, its salt raw material and preparation

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Experimental program
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Effect test

Embodiment 1

[0030] Chromatographic conditions and system suitability test

[0031] Sephadex G-10 (40-120 μm) is used as filler, the inner diameter of the glass column is 1.3-1.8 cm, and the bed volume is 50-200 ml. Mobile phase A is 0.01mol / L phosphate buffer containing 3.5% ammonium sulfate (take disodium hydrogen phosphate 2.19g and sodium dihydrogen phosphate 0.54g, add water 1000ml to dissolve, adjust the pH value to 7.0), mobile phase B is 0.01% sodium lauryl sulfate solution; the flow rate is 1ml per minute; the detection wavelength is 254nm. Use mobile phase A as the mobile phase, inject 200 μl of 1 mg / ml blue dextran 2000 solution into the sample for determination, the number of theoretical plates should not be less than 900, the tailing factor should be 0.75-1.5, and the reference solution should be mobile phase B For the mobile phase, repeated injection of 200μl, the relative deviation of the peak area value should be less than 5.0%.

[0032] Preparation of reference substance...

Embodiment 2

[0035] Same as in Example 1, the preparation method of the reference substance solution: accurately weigh 5 mg of the cefepime reference substance, add borax-sodium carbonate buffer solution (pH=11) to dissolve and dilute to 50 ml, shake well, take a water bath at 40° C. for 1 hour, and cool to room temperature, sample injection and determination of the resulting spectrum as figure 2 .

Embodiment 3

[0037] With embodiment 1, only the preparation of reference substance solution is the preparation of reference substance solution: accurately weigh 5 mg of cefepime reference substance, add 40 ml of water to dissolve, adjust pH value to 11.5 with 0.05N sodium carbonate solution, dilute to 50 ml with water, Shake well, leave at room temperature for 8 hours, and set aside. The chromatogram obtained by the injection measurement is as follows image 3 .

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Abstract

This invention relates to process method to test cefuroxime and its salt materials and the method for polymer comparing product solution. The invention solves the comparing cefuroxime and dilutes it to the needed concentration and adjusts its Ph value above nine as alkalescence solution and to make it totally associated under certain temperature and time. The process method in the invention has complete cefuroxime and stable associated substance and stable peak area of associated substance.

Description

technical field [0001] The present invention relates to the assay method of medicine and its raw material, in particular to the assay method used in the category of cefepime. Background technique [0002] At present, the Chinese Pharmacopoeia 2000 edition has recorded cefoperazone sodium, ceftazidime, ceftriaxone sodium, the assay method of the polymer in cefotaxime sodium, and the preparation method of its reference substance solution is to take cefoperazone, ceftazidime, ceftriaxone, cefotaxime The oxime reference substance is dissolved in water and diluted to the required concentration. The solution is acidic and can be used after preparation. [0003] Preparation of cefoperazone polymer reference substance solution: take about 25 mg of cefoperazone reference substance (cefoperazone acid pH=2~4), weigh it accurately, put it in a 250ml measuring bottle, add water to dissolve and dilute to the mark, shake well Ready to use. [0004] Preparation of ceftazidime polymer refe...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06
Inventor 闵翠娥谭胜连卢志坤廖锐仑
Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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