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Determination method of allylamine and impurities thereof

A method of determination, the technology of allylamine, applied in the field of chemical analysis, can solve the problems of no ultraviolet absorption or weak absorption, difficult separation, inability to separate and detect, etc., and achieve the effect of strong specificity, high accuracy and convenient operation

Pending Publication Date: 2022-04-29
湖北华世通生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0007] At present, there is no literature report on the detection method of allylamine content and impurities. According to the structures of the six impurities in the above table, they have no UV absorption or weak absorption, so the seven substances cannot be separated by high performance liquid chromatography. and detected; and using gas chromatography, impurity chlorinated isopropane, n-propylamine, chlorinated propene and allylamine have closer boiling points, and chlorinated propene and allylamine molecules are similar in polarity, so it is difficult to separate them

Method used

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  • Determination method of allylamine and impurities thereof
  • Determination method of allylamine and impurities thereof
  • Determination method of allylamine and impurities thereof

Examples

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Embodiment 1

[0064] The present embodiment provides a kind of assay method of allylamine content, comprising:

[0065] Diluent: methanol: acetonitrile (80:20).

[0066] Blank solution: same as diluent.

[0067] Reference substance solution: take about 400mg of MAA reference substance, weigh it accurately, put it in a 50ml measuring bottle, dilute to the mark with diluent, and shake well. Prepare 2 copies in parallel.

[0068] Test solution: Take 400mg of MAA test product, weigh it accurately, put it in a 50ml measuring bottle, dilute to the mark with diluent, and shake well. Prepare 2 copies in parallel.

[0069] S2, detection;

[0070] The above-mentioned reference substance solution 1, reference substance solution 2 and the test solution were injected into a gas chromatograph for detection, and the content of allylamine was obtained according to the external standard method.

[0071] Specifically, the chromatographic conditions are as follows:

[0072] Gas chromatograph: Agilent789...

Embodiment 2

[0084] This embodiment provides a method for the determination of allylamine-related impurities, including:

[0085] S1, preparation of reference substance solution and test solution

[0086] Reference substance stock solution A: Weigh 120mg of chloropropene reference substance, weigh it accurately, put it in a 10ml measuring bottle, dissolve it with acetonitrile and dilute to the mark, shake well; pipette 1ml of the above solution, put it in a 10ml measuring bottle, and dilute it with Dilute to volume and shake well.

[0087] Reference substance solution 1: Accurately pipette 1ml of the above-mentioned reference substance stock solution A, put it in a 10ml measuring bottle, dilute to the mark with diluent, and shake well.

[0088] Reference substance stock solution B: Weigh 80mg of allylamine reference substance, 120mg of chloroisopropane reference substance, 160mg of propylamine reference substance, 160mg of 1,5-hexadiene reference substance, 240mg of diallylamine reference...

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Abstract

The invention relates to the technical field of chemical analysis technologies, in particular to a method for determining allylamine and impurities thereof. The method for determining the allylamine and the impurities thereof comprises the step of determining the allylamine and the impurities thereof in an allylamine product by utilizing gas chromatography. Wherein the detection conditions are as follows: a chromatographic column is a 5% diphenyl-95% dimethyl polysiloxane capillary chromatographic column; the temperature programming comprises the following steps: keeping the initial temperature at 30-50 DEG C for 2-5 minutes, raising the temperature to 60-80 DEG C at the speed of 2-20 DEG C / min, keeping the temperature for 1-10 minutes, raising the temperature to 200-250 DEG C at the speed of 2-20 DEG C / min, and keeping the temperature for 1-10 minutes. The method is suitable for separation and detection of the allylamine and the six impurities thereof, separation and content detection of the allylamine and the six impurities thereof can be achieved at the same time, and the separation and detection efficiency is improved.

Description

technical field [0001] The invention relates to the technical field of chemical analysis technology, in particular to a method for determining allylamine and its impurities. Background technique [0002] Sevelamer Carbonate, the chemical name is the polymer carbonate of 2-propen-1-amine and epichlorohydrin, the CAS number is 845273-093-0, the molecular formula is , and the trade name is Renvela. As a drug for the treatment of hyperphosphatemia, it was developed by Genzyme of the United States. It was first launched in the United States in March 2008 and approved in the European Union in June 2009. The approved dosage forms include tablets and dry suspensions. Renvela is the next-generation product of Renagel (sevelamer hydrochloride). This product does not contain calcium and other metals. It is a non-absorbable phosphorus binder that also acts as a carbonate buffer. Sevelamer Carbonate uses allylamine as the starting material, undergoes free radical polymerization to obtai...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/68G01N30/86
CPCG01N30/02G01N30/06G01N30/68G01N30/8634G01N2030/047
Inventor 蔡兰陈露梁樱张林张翰波
Owner 湖北华世通生物医药科技有限公司
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