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A kind of method for measuring edetate calcium sodium content in medicine

A technology for determining the content of edetate calcium and sodium in clevidipine butyrate and the field of determining the content of edetate calcium and sodium in medicines can solve the problems of volumetric content determination and achieve the determination Accurate results, small peak width, and small main peak tailing factor

Active Publication Date: 2018-07-13
李宏 +1
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Problems solved by technology

[0003] "Chinese Pharmacopoeia" 2015 edition, the second part of the quality standard of edetate calcium and sodium adopts the volumetric method to determine its content and the minimum sampling volume is at least 50mg, and the content of edetate calcium and sodium in clevidipine butyrate fat emulsion is less than 0.05mg / L, so its content cannot be determined by volumetric method

Method used

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  • A kind of method for measuring edetate calcium sodium content in medicine
  • A kind of method for measuring edetate calcium sodium content in medicine
  • A kind of method for measuring edetate calcium sodium content in medicine

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Embodiment 1

[0035] A method for measuring edetate calcium sodium content in clevidipine butyrate fat emulsion injection comprises the steps:

[0036] (1) Prepare the sample to be tested: take 20ml of the sample and put it in a separatory funnel, add 4ml of ethanol, mix well, add a little sodium chloride and 20ml of a mixture of ethyl acetate-ether (1:1), and shake vigorously. Stand to separate the layers, transfer the aqueous layer to an evaporating dish, add 10ml of 1% sodium chloride solution and 1ml of ethanol to the organic solvent layer for extraction, combine the aqueous solution, and evaporate to dryness. Add diluent to the residue (dissolve 10 grams of ferric sulfate in 780ml of water, add 50ml of 0.5mol / L sulfuric acid solution, adjust the pH to 2.0 with 1mol / L sodium hydroxide, add water to dilute to 1000ml) to dissolve and transfer to 10ml In the bottle, dilute to the mark with diluent and shake well to get the sample to be tested;

[0037] (2) Preparation of standard solution...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for measuring content of sodium calcium edetate in a medicine and more specifically relates to a method for measuring the content of the sodium calcium edetate in Cleviprex fat emulsion injection. According to the method, liquid chromatogram is used for detecting the sodium calcium edentate; before detection, pre-column derivatization is carried out on the sodium calcium edetate so that the sodium calcium edetate can be converted into sodium ion EDTA; then, spherical graphite carbon serves as filler of a chromatographic column, and a mixed solution of a ferric sulfate water solution and ethanediol serves as a mobile phase for detection, wherein the pH of the mixed solution is 1-2. When the method is adopted for detection, main peak trailing factors are optimal, the number of theoretical plates is large, the peak width is small, symmetry is good, and the content of the sodium calcium edetate in the medicine can be precisely measured.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for determining the content of calcium and sodium edetate in medicines, and more particularly to a method for determining the content of calcium and sodium edetate in clevidipine butyrate. Background technique [0002] Clevidipine butyrate is a third-generation novel short-acting dihydropyridine calcium channel antagonist developed by AstraZeneca in the United Kingdom. It was first launched in the United States in August 2008 under the trade name Cleviprex. It is used for the treatment of high blood pressure that is not suitable for oral administration or is ineffective for oral administration, and it can also be used for the treatment of acute elevation of blood pressure after surgery. In addition, fat emulsion injection is susceptible to catalytic oxidation by metal ions, which affects the stability of the product during preparation and use. Therefore, a metal io...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 李宏毛黎静陈沛单陈静芳范玲玲吴杰
Owner 李宏
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