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Method for detecting novel etimicin sulfate related substances

A technology of etimicin sulfate and related substances, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve the problems of affecting development, inapplicability of trifluoroacetic acid, low sensitivity and accuracy of substance detection, etc.

Active Publication Date: 2012-05-02
WUXI JIMIN KEXIN SHANHE PHARMA +1
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

[0018] The 2010 edition of the Chinese Pharmacopoeia discloses a method for the determination of related substances of etimicin sulfate. The method adopts the HPLC method and uses 0.2mol / L trifluoroacetic acid-methanol (84:16) as the mobile phase, but this mobile phase is too corrosive, the sensitivity and accuracy of the detection of related substances are low, and trifluoroacetic acid is not suitable for LC-MS determination, which affects the development of some follow-up research work

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  • Method for detecting novel etimicin sulfate related substances
  • Method for detecting novel etimicin sulfate related substances
  • Method for detecting novel etimicin sulfate related substances

Examples

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Embodiment 1

[0080] Precisely weighed reference substances of aminoglycoside related substances (ETM-10, ETM-7, ETM-12, ETM-6, ETM-5, ETM-3; they were all isolated from the raw drug etimicin sulfate, and the purity was > 95%) each appropriate amount, add water respectively to prepare a reference substance stock solution containing about 0.001-10mg of relevant impurities per 1ml; accurately draw an appropriate amount of each of the above aminoglycoside-related substance reference substance stock solutions, transfer to the same volumetric flask, add water to dilute To the scale, prepare a mixed reference solution of aminoglycosides related substances, wherein the concentration of each related substance is 500 μg / ml). Chromatographic column: Gemini NX C18 (4.6 mm×150 mm, 5 μm). Mobile phase: Phase A: water-ammonia-glacial acetic acid (96:3.6:0.4), phase B: methanol. The gradient elution method was used to determine the content by HPLC-ELSD, and the area normalization method was used to calcu...

Embodiment 2

[0082] Precisely weighed reference substances of aminoglycoside related substances (ETM-10, ETM-7, ETM-12, ETM-6, ETM-5, ETM-3; they were all isolated from the raw drug etimicin sulfate, and the purity was > 95%) each appropriate amount, add water respectively to make a reference substance stock solution containing about 0.001-10mg of relevant impurities per 1ml; accurately absorb an appropriate amount of each of the above aminoglycoside-related substance reference substance stock solutions, transfer to the same volumetric flask, add water to dilute To the scale, prepare a mixed reference solution of aminoglycoside related substances, wherein the concentration of each related substance is 300 μg / ml). Chromatographic column: Gemini NX C18 (4.6 mm×150 mm, 5 μm). Mobile phase: Phase A: water-ammonia-glacial acetic acid (96:3.6:0.4), phase B: methanol. The gradient elution method was used to determine the content by HPLC-ELSD, and the area normalization method was used to calcula...

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Abstract

The invention relates to a method for detecting novel aminoglycoside antibiotic etimicin sulfate related substances, which comprises the following steps of: precisely weighing a proper amount of each of etimicin sulfate related substance comparison products, and adding water to the etimicin sulfate related substance comparison products respectively so as to obtain etimicin sulfate related substance comparison product stock solutions with a certain concentration; and precisely absorbing a proper amount of each of aminoglycoside related substance comparison product stock solutions, transferring the aminoglycoside related substance comparison product stock solutions to the same volumetric flask, and adding water for diluting until the required scale is reached so as to obtain aminoglycoside impurity mixed comparison product solutions, wherein flowing phases comprise a phase A and a phase B, the phase A is water-ammonia water-glacial acetic acid (96 : 3.6 : 0.4), and the phase B is methanol. A gradient elution method is employed, a measuring process for the novel aminoglycoside antibiotic etimicin sulfate related substances is carried out by using HPLC-ELSD (High Performance Liquid Chromatography-Evaporative Light Scattering Detector), and the content of the novel aminoglycoside antibiotic etimicin sulfate related substances is calculated by an area normalization method.

Description

Technical field: [0001] The invention relates to a novel detection method for the related substances of etimicin sulfate, an aminoglycoside antibiotic. Specifically, it is a new method for detecting etimicin sulfate related substances using HPLC-ELSD instrument and gradient elution method. Background technique: [0002] Etimicin sulfate is a new generation of semi-synthetic aminoglycoside antibiotics with high efficiency, low toxicity and resistance to drug-resistant bacteria, which was developed by Chinese researchers and has independent intellectual property rights. It is the only one that has obtained the national first-class new drug certificate. Anti-infective drugs. [0003] Etilmicin sulfate injection is suitable for Escherichia coli, Klebsiella pneumoniae, Serratia, Citrobacter, Enterobacter, Acinetobacter, Proteus, Haemophilus Various infections caused by Infectious Bacillus, Pseudomonas aeruginosa and Staphylococcus. Clinical studies have shown that this product...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/26G01N30/34
Inventor 吴凌云汪豪张智杰夏冰俞婷易斌
Owner WUXI JIMIN KEXIN SHANHE PHARMA
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