Method for detecting content of 3-amino-2-piperidone in compound amino acid injection

A technology of compound amino acid and piperidone, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of long equilibration time of HILIC chromatographic column, poor separation effect, complex components of compound amino acid injection, etc., and achieve high sensitivity and balance Fast, reproducible results

Active Publication Date: 2020-06-26
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • Method for detecting content of 3-amino-2-piperidone in compound amino acid injection
  • Method for detecting content of 3-amino-2-piperidone in compound amino acid injection
  • Method for detecting 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 a compound amino acid injection. According to the invention, the content of 3-amino-2-piperidone in the compound amino acid injection is detected by high performance liquid chromatography; chromatographic conditions overcome the defectsthat a C18 chromatographic column is weak in retention and an amino column and an HILIC chromatographic column are difficult to balance, ion pair chromatography is poor in reproducibility and the like. The method has the advantages of fast chromatographic column balance, extremely good specificity, high sensitivity, good accuracy, good reproducibility, low quantification limit and the like, the method is simple to operate and fast in analysis, the diluted sample is directly separated and analyzed on line by using the strong cation exchange chromatographic column, and the method is simpler andfaster compared with a traditional method for manually treating the sample by using cation exchange resin. The detection method can be used for qualitative or quantitative analysis of 3-amino-2-piperidone in other amino acid products or ornithine hydrochloride, arginine and other bulk drugs.

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 Applications(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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