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Method for detecting impurities in choline alfoscerate

A technology of choline alfoscerate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of affecting the quality of medicines and not being able to effectively detect impurities in choline alfoscerate, and achieve good repeatability and stability performance, improve quality monitoring standards, and effectively monitor the effect

Active Publication Date: 2015-03-25
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, during the production and storage of choline alfoscerate, due to the influence of different process factors and environmental factors (such as temperature, oxidation and light, etc.), some impurities may be produced, which will directly affect the quality of the drug. Therefore, Need a kind of analytical method, can detect the type and content of various impurities in choline alfoscerate, thereby reach the purpose of controlling the quality of choline alfoscerate
There is currently no method that can effectively detect impurities in choline alfoscerate

Method used

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  • Method for detecting impurities in choline alfoscerate
  • Method for detecting impurities in choline alfoscerate
  • Method for detecting impurities in choline alfoscerate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0183] Mix choline alfoscerate, choline chloride, glycerol phosphatidylinositol, empty capsule shell and glycerin with water, and filter after mixing evenly to obtain choline alphosate mixed solution A. Contains choline alfosate 50mg, choline chloride 0.25mg, glycerol phosphatidylinositol 0.25mg, empty capsule shell 50mg, glycerin 3mg.

[0184] Take 20 μL of the choline alfoscerate mixed solution A, inject it into a Shimadzu liquid chromatograph, and use an Alltech 2000ES evaporative light scattering detector for detection.

[0185] Shimadzu liquid chromatograph adopts LC-10ATvp pump, CBM-20A controller, CLASS-VP chromatography workstation;

[0186] The drift tube temperature of the Alltech 2000ES evaporative light scattering detector is 80°C, the atomizing gas is nitrogen, the atomizing gas flow rate is 2.5L / min, and the carrier gas pressure is 0.15MPa;

[0187] The chromatographic conditions are: Shiseido CAPCELL PAK SCX chromatographic column, the particle size of the chro...

Embodiment 2

[0198] Take 500 mg of the choline alfoscerate sample, place it in a 10 ml volumetric flask, add water to dissolve and constant volume, and shake evenly to obtain the choline alfoscerate sample solution to be tested.

[0199] Measure 20 μ L of choline alfoscerate test sample solution, detect according to the liquid chromatography detection method in the embodiment of the present invention 1, obtain the first liquid phase chromatogram of test sample solution of choline alfoscerate, as figure 2 as shown, figure 2 It is the first liquid chromatogram of the choline alfoscerate test sample solution obtained in Example 2 of the present invention. Depend on figure 2 Can obtain the retention time of main impurity in the choline alfoscerate sample, the result is as shown in table 3, and table 3 is in the choline alfoscerate test sample solution that the embodiment of the present invention 2,3,5,7,9 and 11 obtain Retention time of major impurities.

Embodiment 3

[0201] Take 500mg of choline alfoscerate sample, place it in a 10ml volumetric flask, add 2ml of 1mol / L hydrochloric acid solution, place it in a water bath at 40°C for 1 hour, add 1mol / L sodium hydroxide solution to dissolve the solution in the volumetric flask Neutralize to neutral, then add water to dissolve and constant volume, shake evenly and filter, take the subsequent filtrate to obtain the sample solution of choline alfoscerate to be tested.

[0202] Measure 20 μ L of choline alfoscerate solution to be tested, and detect it according to the liquid chromatography detection method in Example 1 of the present invention. The difference is that the volume ratio of mobile phase B acetonitrile and ammonium formate solution in this example is 35 :65. Obtain the first liquid phase chromatogram of choline alfoscerate test sample solution, as image 3 as shown, image 3 It is the first liquid chromatogram of the choline alfoscerate test sample solution obtained in Example 3 of...

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Abstract

The invention discloses a method for detecting impurities in choline alfoscerate. The method comprises the following steps: with a mixed solution of 0.0005-0.002mol / L of ammonium formate solution and acetonitrile as a moving phase A and with a mixed solution of 0.03-0.05mol / L of ammonium formate solution and acetonitrile as a moving phase B, performing primary liquid chromatography detection on a choline alfoscerate test sample solution by a binary gradient elution process to obtain the contents of the impurities glycerol, choline chloride and glycerol phosphatidyl inositol; with acetonitrile and water as a moving phase, performing secondary liquid chromatography detection on the choline alfoscerate test sample to obtain the content of the impurity, namely glycerin phosphatidyl ethanolamine. According to the method provided by the invention, different chromatographic conditions can be set up for detecting different impurities so as to obtain the contents of all the known impurities, so that one-sidedness of judging the quality of the choline alfoscerate by only detecting some impurities and an aim of monitoring the quality of the choline alfoscerate comprehensively and effectively is achieved.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for detecting impurities in choline alfoscerate. Background technique [0002] Alzheimer's disease is a progressive neurodegenerative disorder, which mainly manifests as memory function attenuation and cognitive impairment, accompanied by various neurological symptoms and behavioral disturbances. Studies have found that the incidence of Alzheimer's disease in my country remains high, among which 2% to 5% of the elderly aged 65 have obvious dementia, and almost half of the elderly over the age of 85 suffer from varying degrees of Alzheimer's disease. With the acceleration of the world's population aging, Alzheimer's disease has become the fourth leading cause of life-threatening elderly people, seriously affecting the health and quality of life of the elderly. Therefore, the research and development of anti-dementia drugs has attracted great attention from the medical circle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 傅超婷云冲刘五生李锦云朱峰王玉娟李富志
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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