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Method for directly determining three degradation products of tryptophan in compound amino acid injection

A technology for compound amino acids and degradation products, which is applied in the field of direct determination of the three degradation products of tryptophan in compound amino acid injections. It can solve the problems of easy interference with the determination of 2-hydroxytryptophan and complex ingredients of compound amino acid prescriptions, and achieve high sensitivity. High performance, strong specificity, good analysis effect

Inactive Publication Date: 2020-08-14
SHANDONG QIDU PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] Because the prescription ingredients of compound amino acid products are complex, and most of the ingredients have similar structures, it is easy to interfere with the determination of dioxindole alanine, kynurenine and 2-hydroxytryptophan
At present, there is no literature or report on the simultaneous detection of these three tryptophan degradation products in compound amino acid injections. content of tryptophan degradation products

Method used

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  • Method for directly determining three degradation products of tryptophan in compound amino acid injection
  • Method for directly determining three degradation products of tryptophan in compound amino acid injection
  • Method for directly determining three degradation products of tryptophan in compound amino acid injection

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Experimental program
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Embodiment 1

[0041] 1. Chromatographic conditions

[0042] Chromatographic column: Shimadzu InertSustain AQ C18 column (250×4.6mm, 5μm), detection wavelength: 254nm, flow rate 1.0mL / min, column temperature: 30°C, injection volume 20μL.

[0043] 2. Solution preparation

[0044] 2.1 Mobile phase A: phosphate buffer (0.01mol / L diammonium hydrogen phosphate solution, adjust the pH value to 7.6±0.1 with trifluoroacetic acid).

[0045] Mobile Phase B: Acetonitrile.

[0046] Gradient elution conditions:

[0047]

[0048] 2.2 The test solution: Precisely measure the compound amino acid injection, dilute with water to make a solution containing tryptophan 0.95mg / mL, as the test solution.

[0049] 2.3 Reference substance solution: Accurately weigh the appropriate amount of reference substances of dioxindole alanine, kynurenine and 2-hydroxytryptophan respectively, add acetonitrile to dissolve and quantitatively dilute with water to make a mixed solution each containing 1.43 μg / mL , as a refer...

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Abstract

The invention belongs to the technical field of drug detection, and particularly relates to a method for directly determining three degradation products of tryptophan in a compound amino acid injection. The three degradation products of tryptophan refer to dioxindole alanine, kynurenine and 2-hydroxytryptophan. The method comprises the following specific steps: (1) preparing the following chromatographic conditions of a liquid chromatograph: a chromatographic column being an octadecylsilane chemically bonded silica chromatographic column; a mobile phase comprising a mobile phase A being a phosphate buffer solution and a mobile phase B being acetonitrile; the flow rate being 0.95-1.05 mL / min; the column temperature being 25-35 DEG C; the sample size being 5-100 [mu]L; gradient elution; andthe detection wavelength being 254 nm; (2) preparing a test solution; (3) preparing a reference substance solution; and (4) determining. The method has the advantages of strong specificity, high sensitivity and good repeatability, solves the technical problems of interference of other amino acid components in the prescription, inaccurate determination result caused by derivative reaction in otherdetection methods, and the like, and ensures the product quality.

Description

technical field [0001] The invention belongs to the technical field of drug detection, in particular to a method for directly measuring three degradation products of tryptophan in compound amino acid injection. Background technique [0002] The prescription of compound amino acid injection contains several to dozens of amino acids such as tryptophan, methionine, arginine, phenylalanine, and leucine. As an important parenteral nutrition drug, it is widely used in clinical , to meet the amino acid needs of patients. Among them, tryptophan, as an essential amino acid in the human body, is prone to degradation under conditions such as light, heat, and oxygen, which affects product quality. Wherein, the structural formulas of tryptophan and its three degradation products are as follows: [0003] [0004] Because the prescription ingredients of compound amino acid products are complex, and most of the ingredients have similar structures, it is easy to interfere with the deter...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675G01N2030/047
Inventor 于黎鑫李福海王艳敏王娜谢建卫刘玉玉王鹏王鑫刘明明白臣生苏凤亚
Owner SHANDONG QIDU PHARMA
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