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A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection

A compound amino acid and piperidone technology, which is applied to measuring devices, instruments, scientific instruments, etc., can solve the problems of complex composition of compound amino acid injection, poor separation effect, long equilibration time of HILIC chromatographic column, etc., and achieve fast equilibrium and quantitative Low limit, high sensitivity effect

Active Publication Date: 2022-05-17
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to provide a detection method for compound amino acid injection with complex components, most components are polar small molecular compounds, poor separation effect on C18 chromatographic column, long equilibration time of HILIC chromatographic column, etc. Method for the content of 3-amino-2-piperidone in compound amino acid injection

Method used

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  • A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection
  • A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection
  • A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection

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Embodiment 1

[0034] A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection, comprising the steps of:

[0035] (1) Preparation of 3-amino-2-piperidone stock solution: Take 83.76 mg of the reference substance 3-amino-2-piperidone, put it in a 100mL volumetric flask, dissolve it with an appropriate amount of ultrapure water and dilute to the mark to prepare Obtain 3-amino-2-piperidone solution for subsequent use;

[0036] Preparation of 3-amino-2-piperidone intermediate solution: Precisely measure 1mL of 3-amino-2-piperidone stock solution in a 10mL volumetric flask, add ultrapure water to dilute to the mark and shake well;

[0037] Preparation of 3-amino-2-piperidone reference solution (abbreviated as APO ST): Accurately measure 1mL of 3-amino-2-piperidone intermediate solution in a 25mL volumetric flask, add ultrapure water to dilute to the mark and shake well. Prepare a 3-amino-2-piperidone reference substance solution with a concentration of 3.32 μg / m...

Embodiment 2

[0045] A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection, comprising the steps of:

[0046] (1) Preparation of 3-amino-2-piperidone stock solution: Take 83.76 mg of reference substance 3-amino-2-piperidone, accurately weighed, place in a 100mL volumetric flask, dissolve and dilute with appropriate amount of ultrapure water To scale, make 3-amino-2-piperidone solution for subsequent use;

[0047] Preparation of 3-amino-2-piperidone intermediate solution: Precisely measure 1mL of 3-amino-2-piperidone stock solution in a 10mL volumetric flask, add ultrapure water to dilute to the mark and shake well;

[0048] Preparation of 3-amino-2-piperidone reference solution (abbreviated as APO ST): Accurately measure 1mL of 3-amino-2-piperidone intermediate solution in a 25mL volumetric flask, add ultrapure water to dilute to the mark and shake well. Prepare a 3-amino-2-piperidone reference substance solution with a concentration of 3.32 μg / mL;

...

Embodiment 3

[0056] A method for detecting the content of 3-amino-2-piperidone in compound amino acid injection, comprising the steps of:

[0057] (1) Preparation of 3-amino-2-piperidone stock solution: Take 83.76 mg of the reference substance 3-amino-2-piperidone, put it in a 100mL volumetric flask, dissolve it with an appropriate amount of ultrapure water and dilute to the mark to prepare Obtain 3-amino-2-piperidone solution for subsequent use;

[0058] Preparation of 3-amino-2-piperidone intermediate solution: Precisely measure 1mL of 3-amino-2-piperidone stock solution in a 10mL volumetric flask, add ultrapure water to dilute to the mark and shake well;

[0059] Preparation of 3-amino-2-piperidone reference solution (abbreviated as APO ST): Accurately measure 1mL of 3-amino-2-piperidone intermediate solution in a 25mL volumetric flask, add ultrapure water to dilute to the mark and shake well. Prepare a 3-amino-2-piperidone reference substance solution with a concentration of 3.32 μg / m...

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Abstract

The invention relates to a method for detecting the content of 3-amino-2-piperidone, in particular to a method for detecting the content of 3-amino-2-piperidone in compound amino acid injection. The present invention utilizes high-performance liquid chromatography to detect the content of 3-amino-2-piperidone in the compound amino acid injection, and the chromatographic conditions overcome the weak retention of the C18 chromatographic column, the difficult balance of the amino column and the HILIC chromatographic column, and the ion-pair chromatography It has the advantages of fast column equilibration, excellent specificity, high sensitivity, good accuracy, good reproducibility, low limit of quantitation, etc., and the method is simple to operate and fast in analysis. It uses a strong cation exchange column Compared with the traditional method of manually processing samples with cation exchange resins, it is simpler and faster to directly separate and analyze the diluted samples online. The detection method of the present invention can be used for qualitative or quantitative analysis of 3-amino-2-piperidone in other amino acid products or raw materials such as ornithine hydrochloride and arginine.

Description

technical field [0001] The invention relates to a method for detecting the content of 3-amino-2-piperidone, in particular to a method for detecting the content of 3-amino-2-piperidone in compound amino acid injection. Background technique [0002] Compound amino acid injection has complex components, most of which are polar compounds. 3-Amino-2-piperidone is a degradation impurity of ornithine hydrochloride in the prescription. There is still no data to prove its safety, and its content needs to be controlled. During the method development process, it was found that in the traditional reverse chromatography using a C18 chromatographic column, 3-amino-2-piperidone, like most other components, had weak retention and was difficult to separate. Even if the proportion of the organic phase is reduced to below 5%, satisfactory results cannot be obtained; ion-pair chromatography enhances the retention of polar compounds on the C18 chromatographic column by adding ion-pair reagents ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/96
CPCG01N30/96
Inventor 关凤徐大星何翠翠
Owner 费森尤斯卡比华瑞制药有限公司
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