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HPLC (high-performance liquid chromatography) detection method of neomycin sulfate component and relevant substances

A technology of neomycin sulfate and related substances, which is applied in the field of chemical detection, and can solve problems such as determination, poor sensitivity, and low specificity

Pending Publication Date: 2018-06-29
广西壮族自治区食品药品检验所
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  • Description
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  • Application Information

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Problems solved by technology

Since neomycin sulfate has no UV absorption, currently used detection methods mainly include microbiological assay (potency method), pre-column derivatization method, HPLC-ELSD method, etc. These methods only measure the content of neomycin sulfate , did not determine its components B and C and related substances. The second part of the Chinese Pharmacopoeia 2015 edition uses thin-layer chromatography to control the content of neomycin sulfate in neomycin sulfate. The operation is cumbersome, the sensitivity is not good, and the specificity is not strong , and there is no control over other related substances

Method used

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  • HPLC (high-performance liquid chromatography) detection method of neomycin sulfate component and relevant substances
  • HPLC (high-performance liquid chromatography) detection method of neomycin sulfate component and relevant substances
  • HPLC (high-performance liquid chromatography) detection method of neomycin sulfate component and relevant substances

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Embodiment 1

[0068] A kind of HPLC detection method of neomycin sulfate component and related substance, comprises the following steps:

[0069] (1) Chromatographic conditions and system suitability test:

[0070] Use hydrophilic octadecylsilane bonded silica gel as filler, chromatographic column: Waters Xselect HSS T3 column, 4.6×250mm, 5μm or equivalent column, mobile phase: 0.15mol / L trifluoroacetic acid solution, flow rate: 1ml / min, injection volume: 10μl, column temperature: 30°C, atomization temperature of CAD detector: 45°C, retention time of neomycin C relative to neomycin B is 0.85-0.95 (about 0.9), new The separation degree between mycin C and main peak neomycin B is not less than 3.0;

[0071] (2) Solution preparation:

[0072] ①Preparation of the test solution: take an appropriate amount of this product, dissolve it with water and dilute it to a solution with a concentration of 1mg / ml, shake well, and use it as the test solution;

[0073] ②Preparation of self-contrast soluti...

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Abstract

The invention belongs to the field of chemical detection, and particularly relates to an HPLC (high-performance liquid chromatography) detection method of a neomycin sulfate component and relevant substances. The HPLC detection method comprises the following steps: (1) testing a chromatographic condition and system applicability; (2) preparing a solution; and (3) determining. The HPLC detection method of the neomycin sulfate component and relevant substances is simple in operation and good in isolation, can detect two major components B and C as well as more relevant substances of neomycin, ishigh in detection efficiency, has good dedication performance, precision and accuracy, can detect more impurities compared with the prior art, can effectively control the components and relevant substances in the neomycin sulfate, and has high practicability.

Description

technical field [0001] The invention belongs to the field of chemical detection, in particular to an HPLC detection method for components of neomycin sulfate and related substances. Background technique [0002] Neomycin sulfate (Neomycin sulfate) is the first aminoglycoside antibiotic discovered. It is a mixture isolated from the metabolites of Streptomyces neomycin by Waksman et al. in 1949. The genus has a good antibacterial effect, and it also has a good effect on Enterobacteriaceae bacteria such as Escherichia coli, Klebsiella, and Proteus. The main components of neomycin sulfate are neomycin B and neomycin C, and neomycin A (neomycin) is one of the degradation products of neomycin B and C. Since neomycin sulfate has no UV absorption, currently used detection methods mainly include microbiological assay (potency method), pre-column derivatization method, HPLC-ELSD method, etc. These methods only measure the content of neomycin sulfate , did not determine its component...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 卢日刚朱健萍刘庄蔚赵庄梁秋霞蒋洁杨欣智朱荣邓鸣何虹
Owner 广西壮族自治区食品药品检验所
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