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A kind of analysis method of fosfomycin tromethamine genotoxic impurity

A technology of fosfomycin trometamol and analysis method, which is applied in the direction of analysis of materials, material separation, and resistance to vector-borne diseases, etc., can solve problems such as failure to meet detection limit requirements, and achieve low cost, strong specificity, and high The effect of sensitivity

Active Publication Date: 2022-07-12
上海峰林生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

According to the detection requirements, the detection limit is generally about 0.1 of the control limit, so the detection limit should be below 0.05ppm, and the conventional gas phase and liquid phase detection methods cannot meet the detection limit requirements

Method used

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  • A kind of analysis method of fosfomycin tromethamine genotoxic impurity
  • A kind of analysis method of fosfomycin tromethamine genotoxic impurity
  • A kind of analysis method of fosfomycin tromethamine genotoxic impurity

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Embodiment 1

[0034] Embodiment 1. a kind of analytical method of fosfomycin tromethamine genotoxic impurity

[0035]This embodiment mainly describes a method for analyzing the genotoxic impurities of fosfomycin tromethamine, and the genotoxic impurities include: allene diethyl phosphate (impurity A), 1-propene diethyl phosphate ( Impurity B), 3-diethyl phosphate-3-methyl-propylene oxide (impurity C), or dimethyl 2-phosphate-3-methyl-propylene oxide (impurity D).

[0036] 1. Reference substance

[0037] Diethyl allene phosphate (impurity A): batch number: 20190408, content: 94.78 %.

[0038] 1-Propylene diethyl phosphate (impurity B): batch number: 20190409, content: 98.79%.

[0039] 3-Diethyl phosphate-3 methyl-propylene oxide (impurity C): batch number: 20190916, content: 94.34%.

[0040] Dimethyl 2-phosphate-3-methyl-propylene oxide (impurity D): batch number: 20190918, content: 94.61%.

[0041] 2. Experimental method

[0042] 2.1 Method

[0043] Take 80 mg of fosfomycin tromethami...

Embodiment 2

[0061] Embodiment 2. a kind of analytical method of fosfomycin tromethamine genotoxic impurity

[0062] The present embodiment mainly describes a kind of analytical method of fosfomycin tromethamine genotoxicity impurity, the difference with embodiment 1 lies in the following technical parameters:

[0063] (1) Mobile phase A is an aqueous solution containing 10% formic acid;

[0064] (2) The test solution was prepared by the following method: take 80 mg of fosfomycin tromethamine crude drug, add it into an aqueous solution containing 95% methanol, vortex to dissolve, shake well, and use it as the test solution.

[0065] (3) The ratio of the value of the weight (mg) of the fosfomycin tromethamine bulk drug to the value of the volume (mL) of the test solution is 90:1;

[0066] (4) The rate of the gradient elution is 0.85mL / min, and the temperature of the eluted chromatographic column is 32°C;

[0067] (5) The high performance liquid chromatography-mass spectrometry method incl...

Embodiment 3

[0069] Embodiment 3. a kind of analytical method of fosfomycin tromethamine genotoxic impurity

[0070] The present embodiment mainly describes a kind of analytical method of fosfomycin tromethamine genotoxicity impurity, the difference with embodiment 2 lies in the following technical parameters:

[0071] (1) Mobile phase A is an aqueous solution containing 1% formic acid;

[0072] (2) The test solution is prepared by the following method: take 80 mg of fosfomycin tromethamine API, add it into an aqueous solution containing 85% methanol, vortex to dissolve, shake well, and use it as the test solution.

[0073] (3) The ratio of the value of the weight (mg) of the fosfomycin tromethamine bulk drug to the value of the volume (mL) of the test solution is 70:1;

[0074] (4) The rate of the gradient elution is 0.75 mL / min, and the temperature of the eluted chromatographic column is 28°C.

[0075] After setting the above technical parameters, the inventor obtained the same results...

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Abstract

The invention provides an analysis method for fosfomycin tromethamine genotoxic impurities, the analysis method comprises: diluting fosfomycin tromethamine with a diluent, and then using high performance liquid chromatography-mass spectrometry combined method to carry out the analysis. For the analysis of impurities, the formic acid solution was used as the mobile phase A, and the acetonitrile solution was used as the mobile phase B, and the elution method was gradient elution. In the formic acid solution, the concentration of formic acid is 0.1-10%. The diluent is an aqueous solution containing 85-95% methanol. The method for analyzing fosfomycin tromethamine genotoxic impurities provided by the invention can more efficiently separate and detect impurities such as allene diethyl phosphate, etc., and has the advantages of strong specificity, high sensitivity, simple, rapid and low cost. advantage.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for analyzing fosfomycin tromethamine genotoxic impurities. Background technique [0002] Fosfomycin tromethamine is an off-white crystalline powder, which is a 1:1 mixture of fosfomycin and 2-amino-2-hydroxymethyl-1,3-propanediol, which can directly prevent bacterial cell wall synthesis. The role of essential pyruvate transferase, its antibacterial spectrum includes Escherichia coli, Shigella, Citrobacter, Proteus, Serratia, Staphylococcus aureus and Pseudomonas aeruginosa and other microorganisms, can be used to treat the corresponding Urinary tract infections and other diseases caused by microorganisms. [0003] Compound Allene Diethyl Phosphate (Impurity A), 1-Propylene Diethyl Phosphate (Impurity B), 3-Diethyl Phosphate-3 Methyl-Propylene Oxide (Impurity C), or Dimethyl 2-Phosphate Ester-3-methyl-propylene oxide (impurity D), etc. are genotoxic impurities remaining in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88Y02A50/30
Inventor 郑玉林刘丽娟陈玉双
Owner 上海峰林生物科技有限公司
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