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Method for performing liquid chromatography and simultaneously performing separation and determination on pyroglutamic acid and dl-methionine sulfoxide impurities in compound amino acid injection 18AA

A technology of methionine sulfoxide and compound amino acid, which is applied in the field of drug quality determination, can solve the problems that the simultaneous separation and detection of pyroglutamic acid and methionine sulfoxide cannot be applied, and there are few reports. good reproducibility

Active Publication Date: 2018-05-04
南京医科大学康达学院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, through literature search, there are few reports on the research on amino acid degradation impurities in compound amino acid pharmaceutical preparations
Only Xie Shenggu et al. reported the study of the degradation impurity pyroglutamic acid in compound amino acid injection 18AA (Journal of Pharmaceutical Analysis, 2015, 35(4), 705-709), but this method cannot be applied to the simultaneous separation and detection of pyroglutamic acid. glutamate and methionine sulfoxide
There is no relevant report on the simultaneous separation and detection of pyroglutamic acid and methionine sulfoxide impurities in Compound Amino Acid Injection 18AA

Method used

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  • Method for performing liquid chromatography and simultaneously performing separation and determination on pyroglutamic acid and dl-methionine sulfoxide impurities in compound amino acid injection 18AA
  • Method for performing liquid chromatography and simultaneously performing separation and determination on pyroglutamic acid and dl-methionine sulfoxide impurities in compound amino acid injection 18AA
  • Method for performing liquid chromatography and simultaneously performing separation and determination on pyroglutamic acid and dl-methionine sulfoxide impurities in compound amino acid injection 18AA

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] A method for simultaneously separating and measuring impurities of pyroglutamic acid and methionine sulfoxide in compound amino acid injection 18AA by liquid chromatography, comprising the following steps:

[0056] 1) Preparation of reference substance stock solution:

[0057] Take the pyroglutamic acid reference substance, accurately weigh it, dissolve it in water and quantitatively dilute it to make a reference substance solution containing about 1mg of pyroglutamic acid in every 1ml, and use it as the pyroglutamic acid reference substance stock solution.

[0058] Take the methionine sulfoxide reference substance, accurately weigh it, dissolve it in water and quantitatively dilute it to make a reference substance solution containing about 1 mg of methionine sulfoxide in every 1 ml, and use it as the methionine sulfoxide reference substance stock solution.

[0059] 2) Preparation of control solution

[0060] Precisely measure an appropriate amount of pyroglutamic acid r...

Embodiment 2

[0078] Embodiment 2 (linear range)

[0079] According to the standard curve method, the content of pyroglutamic acid and methionine sulfoxide impurities in the test product was calculated by peak area.

[0080] Accurately measure pyroglutamic acid control solutions (1), (2), (3), (4), (5) and (6) and methionine sulfoxide control solutions (1), (2), (3), 100 μl each of (4), (5) and (6) were respectively injected into a high performance liquid chromatograph, the chromatogram was recorded, and the peak area was measured. With the peak area A as the ordinate and the injection concentration C as the abscissa, perform linear regression and calculate the correlation coefficient (r).

[0081] Table 2 Pyroglutamic acid linearity and range test results

[0082]

[0083] Table 3 Methionine sulfoxide linearity and range test results

[0084]

[0085] The results showed that pyroglutamic acid was in the range of 0.19~201.20μg·ml -1 Within the concentration range, the linear curve...

Embodiment 3

[0086] Embodiment 3 (precision)

[0087] 1. Injection precision:

[0088] Accurately measure an appropriate amount of pyroglutamic acid reference substance stock solution, dilute it with water, and make a solution containing about 10 μg of pyroglutamic acid in every 1 ml. The RSD for the peak area was 1.85% (Table 4).

[0089] Precisely measure an appropriate amount of methionine sulfoxide reference substance stock solution, dilute it with water, and prepare a solution containing about 10 μg of methionine sulfoxide in every 1 ml. The RSD was 1.82% (Table 5). It can be seen from Table 4 and Table 5 that the repeatability is good.

[0090] Table 4 Pyroglutamic acid linearity and range test results

[0091] Injection order

Peak area

1

623609.0

2

628198.0

3

604374.0

4

625242.0

5

632829.0

6

608092.0

average

620390.7

RSD(%)

1.85

[0092] Table 5 Methionine sulfoxide lineari...

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Abstract

The invention discloses a method for performing liquid chromatography and simultaneously performing separation and determination on pyroglutamic acid and dl-methionine sulfoxide impurities in compoundamino acid injection 18AA. The method comprises the following steps: firstly determining a test product solution in a high-efficient liquid chromatograph; then calculating contents of the pyroglutamic acid and dl-methionine sulfoxide impurities in the test product by using peak area according to a standard curve method. The determination method disclosed by the invention has the advantages that the determination method is simple, convenient and feasible, is short in analysis time, is high in specificity, and good in reproducibility; moreover, the pyroglutamic acid and dl-methionine sulfoxideimpurities in the compound amino acid injection 18AA can be effectively determined.

Description

technical field [0001] The invention relates to the technical field of drug quality determination methods, in particular to a method for simultaneously separating and detecting the glutamic acid-degraded impurity pyroglutamic acid and methionine-degraded impurity methionine sulfoxide in compound amino acid injection 18AA by using a high-performance liquid chromatograph. Background technique [0002] Compound Amino Acid Injection 18AA is mainly used for patients with insufficient protein intake, malabsorption and other amino acids that cannot meet the metabolic needs of the body, and is also used to improve the nutritional status of patients after surgery. The rapid development of Compound Amino Acid Injection 18AA has enabled clinical critically ill patients to receive good parenteral nutrition support, ensured the body's positive nitrogen balance, and promoted protein synthesis. As the public and the media pay more and more attention to drug safety, impurities in drugs have...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 李莉张明马炳原秦雅茹乔萍张闯熊肖男
Owner 南京医科大学康达学院
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