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Method for simultaneous separation and determination of methionine sulfoxide and methionine sulfone impurities in compound amino acid injection 18aa by liquid chromatography

A technology of methionine sulfoxide and compound amino acids, which is applied in the field of drug quality determination, to achieve the effects of strong specificity, good reproducibility, and controllable quality

Active Publication Date: 2020-11-17
KANGDA COLLEGE OF NANJING MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, through literature search, there is no relevant report on the detection method for the simultaneous separation and detection of methionine sulfoxide and methionine sulfone impurities in compound amino acid injection 18AA

Method used

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  • Method for simultaneous separation and determination of methionine sulfoxide and methionine sulfone impurities in compound amino acid injection 18aa by liquid chromatography
  • Method for simultaneous separation and determination of methionine sulfoxide and methionine sulfone impurities in compound amino acid injection 18aa by liquid chromatography
  • Method for simultaneous separation and determination of methionine sulfoxide and methionine sulfone impurities in compound amino acid injection 18aa by liquid chromatography

Examples

Experimental program
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Effect test

Embodiment 1

[0054] A method for simultaneously separating and measuring methionine sulfoxide and methionine sulfone impurities in compound amino acid injection 18AA by liquid chromatography, comprising the following steps:

[0055] 1) Preparation of reference substance stock solution:

[0056] 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 per 1 ml, and use it as the methionine sulfoxide reference substance stock solution.

[0057] Take the methionine sulfone 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 sulfone per 1 ml, and use it as the methionine sulfone reference substance stock solution.

[0058] 2) Preparation of control solution

[0059]Accurately measure an appropriate amount of methionine sulfoxide ref...

Embodiment 2

[0077] Embodiment 2 (linear range)

[0078] According to the preparation method of methionine sulfoxide control solution and methionine sulfoxide control solution in Example 1, respectively prepare methionine sulfoxide control solutions (1), (2), (3), (4), (5) and (6) and Methionine sulfone control solutions (1), (2), (3), (4), (5) and (6).

[0079] Accurately measure methionine sulfoxide control solutions (1), (2), (3), (4), (5) and (6) and methionine sulfoxide control solutions (1), (2), (3), (4 ), (5) and (6) each 100 μl, respectively injected in the high performance liquid chromatograph, record the chromatogram, measure the peak area. Take the peak area A as the ordinate, and the injection concentration C as the abscissa, perform linear regression, and calculate the correlation coefficient (r).

[0080] Table 2 Methionine sulfoxide linearity and range test results

[0081]

[0082] Table 3 Methionine sulfone linearity and range test results

[0083]

[0084] The ...

Embodiment 3

[0085] Embodiment 3 (precision)

[0086] 1. Injection precision:

[0087] Precisely measure an appropriate amount of methionine sulfoxide reference substance stock solution, dilute it with water, and make a solution containing about 10 μg of methionine sulfoxide in every 1 ml. RSD was 0.16% (Table 4).

[0088] Precisely measure an appropriate amount of methionine sulfone reference substance stock solution, dilute it with water, and make a solution containing about 10 μg of methionine sulfone per 1 ml. Under the chromatographic conditions of Example 1, continuous sampling is performed for 6 times, and the RSD of the methionine sulfone peak area is 1.84 %(table 5). It can be seen from Table 4 and Table 5 that the repeatability is good.

[0089] Table 4 Methionine sulfoxide linearity and range test results

[0090]

[0091]

[0092] Table 5 Methionine sulfone linearity and range test results

[0093] Injection order Peak area 1 28458 2 29655 3...

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Abstract

The invention discloses a method for simultaneously separating and determining methionine sulfoxide and methionine sulfone impurities in a compound amino acid injection 18AA through liquid chromatography. The method comprises the steps of firstly determining a test solution in a high performance liquid chromatograph, and then calculating the contents of the methionine sulfoxide and the methioninesulfone impurities in the test solution through a peak area according to a standard curve method. The detecting method provided by the invention is simple, convenient, feasible, short in analysis time, strong in specificity, good in repeatability, and capable of effectively determining and separating the methionine sulfoxide and the methionine sulfone impurities in the compound amino acid injection 18AA.

Description

technical field [0001] The invention belongs to the technical field of drug quality determination methods, and in particular relates to a method for separating and detecting methionine degradation impurities methionine sulfoxide and methionine sulfone in compound amino acid injection 18AA by high performance liquid chromatography. 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 injections enables clinical critically ill patients to receive good parenteral nutrition support, ensures the body's positive nitrogen balance, and promotes protein synthesis. [0003] As the public and the media pay more and more attention to drug safety, impurities in drugs have become important indicators in drug qu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 李莉张明顾浦中马炳原崔红艳李宗豪钟家棋沈梦元蒋荷
Owner KANGDA COLLEGE OF NANJING MEDICAL UNIV
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