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Method for detecting arbekacin sulfate and impurities thereof

A detection method and impurity technology, which is applied in the detection field of arbekacin sulfate and its impurities, can solve the problems of poor controllability and inability to effectively measure the quality of related substances, and achieve strong operability, environmental friendliness, Improve the effect of life cycle

Active Publication Date: 2020-05-15
江苏省食品药品监督检验研究院 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The current inspection method still has some problems in controlling and evaluating the quality of drugs. The controllability of the content determination is not very good, and the quality of related substances cannot be effectively measured. The inspection method for content and related substance inspection items can be further improved

Method used

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  • Method for detecting arbekacin sulfate and impurities thereof
  • Method for detecting arbekacin sulfate and impurities thereof
  • Method for detecting arbekacin sulfate and impurities thereof

Examples

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Effect test

Embodiment 1

[0033] 1 Instruments and reagents

[0034] Dionex Corporation ICS-3000 high-performance liquid chromatography, pulsed amperometric electrochemical detector (3mm gold electrode); data analysis using Chameleon data analysis software (Dionex Corporation Chromeleon Client Program); high-purity helium (Nanjing Tianze Gas Co., Ltd. responsible company); Sartorius electronic balance and Millipore deionized water generator.

[0035] Kanamycin B reference substance was purchased from China National Institutes for Food and Drug Control, arbekacin, dibekacin reference substances and arbekacin isomers were provided by Changzhou Fangyuan Pharmaceutical Co., Ltd. The batch number (0205-B) is from company A; the batch number (ABK-2, ABK-3, ABK-4, ABK-5, ABK-6) is from company B: trifluoroacetic acid and pentafluoropropionic acid are provided by J&KCHEMICAL (HPLC grade , 99.9%, Beijing, China); 50% carbon dioxide-free sodium hydroxide aqueous solution was provided by SIGMA-AIDRICH Fluka (Ana...

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Abstract

The invention relates to Arbekacin sulfate, in particular to a method for detecting Arbekacin sulfate and impurities thereof. The method for detecting the Arbekacin sulfate and the impurities of the Arbekacin sulfate is obtained through optimization. The HPLC-PAD method for determining the content of the arbekacin sulfate and the related substances is established for the first time, and compared with a Japanese pharmacopeia loading method, the specificity is good, and the method is durable.

Description

technical field [0001] The invention relates to arbekacin sulfate, in particular to a detection method for arbekacin sulfate and impurities thereof. Background technique [0002] Arbekacin Sulfate (ABK) is an aminoglycoside antibiotic discovered by Umezawa Paifu of the Institute of Microbial Chemistry in Japan and developed by the Japanese Meiji Seika Pharmaceutical Company. It was put on the market in 1990. The antibacterial mechanism of arbekacin is to inhibit the synthesis of bacterial proteins. Arbekacin is similar to dibekacin, stable to various inactivating enzymes, can form a three-dimensional barrier to inactivating enzymes structurally, and has a high degree of antagonistic effect on aminoglycoside inactivating enzymes. The improvement of clinical symptoms of this type of drug is proportional to the dosage, which is dose-dependent, and has the strongest post-antibiotic effect (PAE) among antibiotics, and it is still valued clinically so far. [0003] The structure...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/64G01N30/86
CPCG01N30/02G01N30/06G01N30/64G01N30/8631
Inventor 袁耀佐吴宇宁张玫朱晓玥赵述强王海东戴俊
Owner 江苏省食品药品监督检验研究院
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