Method for assaying related substances in lysine acetate by high-performance liquid chromatography

A technology of high performance liquid chromatography and lysine acetate, which is applied in the field of determination of related substances in lysine acetate by high performance liquid chromatography, achieving the effects of good repeatability, strong operability and high precision

Inactive Publication Date: 2016-05-25
SHANGHAI JINGFENG PHARMA
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  • Claims
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Problems solved by technology

Therefore, it is difficult to completely detect it with general analytical methods, and it needs to be derivatized to generate derivatives with UV-visible absorption or fluorescence response before analysis and determination

Method used

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  • Method for assaying related substances in lysine acetate by high-performance liquid chromatography
  • Method for assaying related substances in lysine acetate by high-performance liquid chromatography
  • Method for assaying related substances in lysine acetate by high-performance liquid chromatography

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Embodiment Construction

[0027] A method for measuring related substances in lysine acetate with high performance liquid chromatography, comprising the steps:

[0028] (1) Steps to establish a chromatographic system

[0029] The chromatographic system was established according to the following conditions: chromatographic column: C18100*4.6mm, column temperature: 40°C, detector: UV detector, 336nm, flow rate: 1.0ml / min, injection volume: 10μl, derivatization reagent: o-benzene Diformaldehyde (OPA), mobile phase A: pH7.4~7.8 sodium dihydrogen phosphate buffer solution, mobile phase B: methanol-water, wherein the volume ratio of methanol to water is 90:10;

[0030] The preparation method of pH 7.4-7.8 sodium dihydrogen phosphate buffer solution is: after dissolving 7.15 g of sodium dihydrogen phosphate and adding 1000 mL of water, adjust the pH value to 7.4-7.8 with NaOH solution.

[0031] The elution gradients of mobile phase A and mobile phase B are shown in Table 1:

[0032] Table 1

[0033] ...

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Abstract

The invention relates to a method for assaying related substances in lysine acetate by high-performance liquid chromatography. According to the method, by taking octadecylsilane bonded silica gel as a chromatographic column and taking a sodium dihydrogen phosphate buffer solution and methanol-water as mobile phases, the contents of the related substances in the lysine acetate can be assayed, so that the masses of the related substances in the lysine acetate can be effectively controlled.

Description

technical field [0001] The invention relates to the technical field of determination of related substances in lysine acetate, in particular to a method for determining related substances in lysine acetate by high performance liquid chromatography. Background technique [0002] Lysine acetate is one of the essential amino acids for the human body. It has the nutritional effect of supplementing protein. It can be used in the preparation of amino acid injections and oral preparations in medicine, and it is also used to prepare amino acid injections and oral preparations; it is an auxiliary drug for diuretics, and it is used to treat causes Lead poisoning caused by the reduction of chloride in the blood; it can form salts with acidic drugs (such as salicylic acid, etc.) to reduce adverse reactions. [0003] Lysine acetate belongs to amino acid drugs, its Chinese pinyin: Cusuan Laiansuan, English name: LysineAcetate, traits: This product is white crystal or crystalline powder; al...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 叶湘武张兆利杨帅兵付爱玲罗斌
Owner SHANGHAI JINGFENG PHARMA
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