Method for measuring content of degraded impurity methionine sulfoxide in compound amino acid injection

A technology of methionine sulfoxide and compound amino acid, which is applied in the field of degrading the content of impurity methionine sulfoxide, achieves good separation, simple method and strong exclusive effect

Active Publication Date: 2016-12-21
SICHUAN KELUN PHARMA CO LTD
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  • Method for measuring content of degraded impurity methionine sulfoxide in compound amino acid injection
  • Method for measuring content of degraded impurity methionine sulfoxide in compound amino acid injection
  • Method for measuring content of degraded impurity methionine sulfoxide in compound amino acid injection

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Embodiment 1

[0031] Precisely measure 1ml of compound amino acid injection, put it in a 10ml measuring bottle, dilute with water to the mark, shake well, and use it as the test solution. Another appropriate amount of methionine sulfoxide reference substance was taken, accurately weighed, dissolved in water and diluted to make a solution containing 5 μg per 1 ml as the reference substance solution. Test according to high performance liquid chromatography (Chinese Pharmacopoeia 2010 edition two appendix ⅤD), with octadecylsilane bonded silica gel as filler; with 0.038mol / L potassium dihydrogen phosphate solution (with 1mol / L potassium hydroxide solution Adjust pH to 6.9)-acetonitrile (88:12) as mobile phase A, with acetonitrile as mobile phase B, carry out gradient elution according to the elution program in Table 1; detection wavelength is 334nm; column temperature is 40 ° C; sample plate temperature at 4°C, set the program of the Agilent sampler and carry out the derivatization reaction, w...

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Abstract

The invention discloses a method for measuring content of degraded impurity methionine sulfoxide in compound amino acid injection; an octadecyl silane bonded silica gel column is used, program setting is made by using Agilent sampler and derivatization is carried out, wavelength of 334 nm is detected after sampling, and the content is calculated according to an external standard method; for mobile phases, 0.038 mol/L of monopotassium phosphate (pH 6.9) and acetonitrile (88:12) acts as mobile phase A, acetonitrile acts as mobile phase B, and gradient diluting is carried out; test article diluent is water, and sampling concentration is 5 Mug/ml; according to the method of the invention, other amino acids and auxiliaries in the formulation are friendly to detection, the method has a good degree of separation and high specificity, the difficulty in detecting methionine sulfoxide in the amino acid compound is overcome, the methionine sulfoxide in a product is effectively controlled, and product quality is guaranteed.

Description

technical field [0001] Embodiments of the present invention relate to the technical field of pharmaceutical analysis, and more specifically, embodiments of the present invention relate to a method for determining the content of the degradation impurity methionine sulfoxide in compound amino acid injection. Background technique [0002] Compound Amino Acid Injection is an intravenous nutritional drug, widely used in clinical nutritional support. The methionine in the prescription is an amino acid containing a thioether bond, which is easily oxidized. The main degradation product is methionine sulfoxide, which is harmful to human health and needs to be controlled. Since there are many kinds of other amino acids in the prescription, it is easy to interfere with the determination of methionine sulfoxide. Therefore, it is necessary to establish a detection method with high accuracy and strong specificity to control the content of methionine sulfoxide in amino acid products. Ther...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88G01N30/06G01N30/24
CPCG01N30/06G01N30/24G01N30/88G01N2030/067G01N2030/8818G01N2030/8872
Inventor 蔡作清黄东刘文军罗成鑫王昌斌
Owner SICHUAN KELUN PHARMA CO LTD
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