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

A reference substance solution, cefepime technology, applied in the direction of measurement device, material separation, analysis of materials, etc., can solve the problems of poor reproducibility, small association peak, larger association peak, etc., to achieve reproducibility Good, stable peak area, stable effect of associates

Active Publication Date: 2005-09-21
GUANGZHOU BAIYUSN TIANXIN PHARMA
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This new method allows for accurate measurements with high accuracy by combining two different solutions together at once without any interference from each other or affecting their properties.

Problems solved by technology

This patented technical problem addressed in this patents relates to improperly associating certain compounds with other chemical groups or molecules during synthesis processes for making medicines that have potential side effects on their patients' health caused by these impurities.

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

Examples

Experimental program
Comparison scheme
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

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Claims

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Application Information

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Owner GUANGZHOU BAIYUSN TIANXIN PHARMA
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