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Determination method of alanyl-glutamine related substances

A technology of alanylglutamine and a determination method, applied in the field of analytical chemistry, can solve the problems of poor separation effect of impurities, poor durability of chromatographic columns, long retention time of impurities, etc., and achieves long service life, good durability and high sensitivity Effect

Pending Publication Date: 2022-01-14
SUZHOU KELUN PHARMA RES CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] Aiming at the shortcomings of the prior art detection of alanyl glutamine and related substances in its preparations, such as poor separation effect of impurities, too long retention time of individual impurities, drift of retention time, and poor durabi

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  • Determination method of alanyl-glutamine related substances
  • Determination method of alanyl-glutamine related substances
  • Determination method of alanyl-glutamine related substances

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Abstract

The invention belongs to the field of analytical chemistry, and particularly relates to a method for determining related substances in alanyl-glutamine or a preparation thereof, and the method adopts HPLC (High Performance Liquid Chromatography) for detection. Wherein a chromatographic column takes octadecyl acylamino bonded silica gel as a filling agent and takes a sodium octanesulfonate solution-acetonitrile (95: 5) as a mobile phase. The method can effectively separate nine related substances of the alanyl-glutamine, is good in specificity and high in sensitivity, and can realize accurate and quantitative determination of the alanyl-glutamine or a preparation of the alanyl-glutamine.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for measuring alanyl glutamine and related substances in preparations thereof by high performance liquid chromatography. Background technique [0002] Alanyl glutamine, the structural formula is as follows: [0003] [0004] It is an amino acid drug commonly used in clinical practice. It has the functions of supplementing essential amino acids for nutrition, maintaining acid-base balance in the body, and enhancing the body's immunity. Many domestic companies have been approved to use this raw material drug in the marketed preparations, such as: Evonik Maxsi Simplified Co., Ltd., Shandong Chenlong Pharmaceutical Co., Ltd., Wuhan Daan Pharmaceutical Co., Ltd., etc. [0005] Impurity research is an important way to evaluate the quality of drugs. Alanyl glutamine may introduce residual raw materials and other related substances during the synthesis process...

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679
Inventor 肖丽萍屠金月钱明明步亚南吴灵静王晶翼
Owner SUZHOU KELUN PHARMA RES CO LTD
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