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High performance liquid chromatography method for determining fosfomycin sodium impurities

A high-performance liquid chromatography, fosfomycin sodium technology, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of fosfomycin sodium impurity, such as high polarity, inability to effectively retain, and high separation polarity, and achieve enhanced Retention of highly polar impurities, improved separation and detection levels, and improved retention

Active Publication Date: 2020-03-17
上海峰林生物科技有限公司
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Problems solved by technology

However, the above-mentioned method has many disadvantages, such as the amino column used is relatively fragile, and due to the high polarity of fosfomycin sodium series impurities and the rapid peak generation, it is impossible to effectively retain and separate complex impurity mixed systems with high polarity

Method used

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  • High performance liquid chromatography method for determining fosfomycin sodium impurities
  • High performance liquid chromatography method for determining fosfomycin sodium impurities
  • High performance liquid chromatography method for determining fosfomycin sodium impurities

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Embodiment 1

[0039] 1. Sample preparation

[0040] 1) The test solution:

[0041] Take about 0.05g of fosfomycin sodium, accurately weighed, put in a 50ml measuring bottle, add mobile phase to dissolve and quantitatively dilute to the mark, shake well, filter, and take the subsequent filtrate as the test solution.

[0042] 2) Reference substance solution:

[0043] Accurately weigh an appropriate amount of cis-acrylphosphate sodium reference substance, add mobile phase to dissolve and quantitatively dilute to make a solution containing 0.015 mg of cis-acrylphosphate per 1 ml, shake well, filter, and take the subsequent filtrate as the reference solution.

[0044] 3) System suitability solution:

[0045] Accurately weigh an appropriate amount of sodium allenyl phosphate, sodium cis allenyl phosphate, phenethylamine salt of 2,3-allyl phosphate and sodium trans allenyl phosphate impurity reference substance, and dilute with mobile phase to form a mixed solution of about 10ug / ml.

[0046] 2....

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Abstract

The invention relates to a high performance liquid chromatography method for determining fosfomycin sodium impurities. According to the high performance liquid chromatography method, a chromatographiccolumn using octadecylsilane chemically bonded silica as a filler is used, a phosphoric acid aqueous solution-methanol mixed solution is used as a mobile phase, the concentration mass fraction of phosphoric acid in the phosphoric acid aqueous solution is 0.04%-0.06%, and the volume ratio of the phosphoric acid aqueous solution to methanol is 99: 1-99: 5. According to the method, the retention ofstrong polar impurities is enhanced, the complex impurity system of fosfomycin sodium can be effectively separated and the method has good universality and specificity of specific impurities and is high in sensitivity, convenient to operate and moderate in analysis time and thus provides effective guarantee for the quality control of the compound.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a high-performance liquid chromatography method for determining fosfomycin sodium impurities. Background technique [0002] Fosfomycin is a new type of broad-spectrum antibiotic jointly developed by Merck (Merck) of the United States and CEPA of Spain in 1967. It is a phosphoric acid derivative in structure, has a unique chemical structure, and has a small molecular weight. Fosfomycin has a unique mechanism of action, can inhibit the early stage of cell wall synthesis, and does not produce cross-resistance to other antibiotics, and is mainly used to treat Gram-negative and positive bacterial infections. [0003] At present, there are mainly 4 varieties of fosfomycin, namely fosfomycin sodium salt, fosfomycin calcium salt, fosfomycin tromethamine salt, and fosfomycin benzylamine salt. Fosfomycin sodium salt and calcium salt were launched in Europe in 1975, and w...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/60
CPCG01N30/88G01N30/60G01N2030/8872
Inventor 郑玉林陈玉双刘丽娟
Owner 上海峰林生物科技有限公司
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