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Method for determining content and impurities of levocarnitine injection and use thereof

A technology for injection and impurities, applied in the determination of levocarnitine injection content and impurities, hydrophilic interaction chromatography determination of levocarnitine injection content and impurities, can solve the requirements of low separation limit and theoretical plate number Reduced, short life of the column and other problems, to achieve the effect of overcoming the hard-to-obtain

Active Publication Date: 2017-06-13
YANTAI UNIV
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Problems solved by technology

The United States Pharmacopoeia selects the chromatographic column as an amino-bonded phase chromatographic column. In the method, the demand for the chromatographic column to be equilibrated for up to 3 hours before sample analysis is too strict, which may easily cause column loss, resulting in drift of retention time and decrease in the number of theoretical plates. Shorter column life and lower resolution limit requirements (≥1.0)

Method used

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  • Method for determining content and impurities of levocarnitine injection and use thereof
  • Method for determining content and impurities of levocarnitine injection and use thereof
  • Method for determining content and impurities of levocarnitine injection and use thereof

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Embodiment Construction

[0033] The following examples help to further understand the present invention, but the present invention is not limited to these contents.

[0034] A method for determining the content and impurities of levocarnitine injection by hydrophilic interaction chromatography.

[0035] 1 material preparation

[0036] Shimadzu LC-20A high performance liquid chromatography system (including LC-20AT pump; DGU-20A degasser; SIL-20A autosampler; CTO-10ASvp column thermostat; SPD-20A UV detector; Lab solution chromatography Workstation); WatersXBridge Amide chromatographic column (4.6mm × 250mm, 3.5μm); 1 / 10,000 electronic balance (AR1140, OhausCorp.Brook, NJ, USA); 1 / 100,000 electronic balance (MS105Du type, METTLER TOLEDO); Electronic pH meter (pHMeter PHS-3C, Shanghai Jingke Industrial Co., Ltd.); ultrasonic cleaner (SK250HP, Wuxi Jianyi Experimental Equipment Co., Ltd.).

[0037] The reference substance of levocarnitine was provided by China National Institutes for Food and Drug Cont...

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Abstract

The invention provides a method for determining the content and impurities of a levocarnitine injection by hydrophilic interaction chromatography. A result of methodology validation shows that the method is high in degree of separation, has an accurate determination result, can be used for controlling relevant substances of the levocarnitine injection, and provides reference for increase of a quality standard of the levocarnitine injection. Meanwhile, the method can be used for determining the content and impurities of the levocarnitine injection.

Description

technical field [0001] This patent relates to a method for determining the content and impurities of levocarnitine injection, specifically a method for determining the content and impurities of levocarnitine injection by hydrophilic interaction chromatography, which belongs to the field of drug analysis. Background technique [0002] Levocarnitine, whose chemical name is (R)-3-carboxy-2-hydroxy-N,N,N-trimethyl-1-propanamine hydroxide, is an essential natural substance in the energy metabolism of mammals. The main function is to assist cells in lipid metabolism and energy production. [0003] E-4-(trimethylammonium)but-2-enoic acid ethyl ester (referred to as impurity A) is the main impurity and degradation product in levocarnitine, its structure contains a conjugated structure, and the response value is much greater than Levocarnitine, which needs to be quantified separately. [0004] The structural formulas of levocarnitine and its impurity A are as follows, [0005] ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 许丽晓耿银银刘万卉
Owner YANTAI UNIV
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