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Method for detecting neomycin sulfate components and related substances

A neomycin sulfate and detection method technology, which is applied in the directions of measuring devices, material separation, and analysis materials, etc., can solve problems such as the inability to effectively separate multiple impurities from neomycin sulfate, and improve the efficiency of neomycin sulfate. Product quality, high sensitivity, and the effect of a simple method

Active Publication Date: 2020-04-17
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] For the detection method of neomycin sulfate in the prior art, the effective separation of multiple impurities and neomycin sulfate, and the effective separation of neomycin sulfate B and neomycin sulfate C components cannot be easily and effectively realized Problem, the invention provides a kind of detection method of neomycin sulfate component and related substance

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  • Method for detecting neomycin sulfate components and related substances
  • Method for detecting neomycin sulfate components and related substances
  • Method for detecting neomycin sulfate components and related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Materials and Methods:

[0032] Instruments: high performance liquid chromatography, evaporative light scattering detector, electronic balance.

[0033] Reagents: methanol, trifluoroacetic acid, neomycin (impurity A), neomycin sulfate B, neomycin sulfate C and paromomycin sulfate reference substance.

[0034] Blank solvent: water

[0035] 1.1 Preparation of solution

[0036] The preparation of each impurity and component stock solution: Weigh the appropriate amount of neomycin (impurity A), neomycin sulfate B, neomycin sulfate C and paromomycin sulfate reference substance respectively, add water to dissolve and dilute to prepare 1mL contains about 1.0mg of the corresponding impurities and component stock solution.

[0037] Preparation of mixed reference solution: Accurately measure the appropriate amount of each stock solution of neomycin (impurity A), neomycin sulfate B, neomycin sulfate C and paromomycin sulfate, add water to dissolve and dilute to make about 1mL ...

Embodiment 2

[0048] Methodology Validation:

[0049] 2.1 System suitability

[0050] Take the above-mentioned mixed control solution for sample injection detection, wherein the mixed reference solution (i.e. system suitability solution) is continuously sampled for 6 needles, according to the above high-performance liquid chromatography conditions for sample injection detection, the injection volume is 20 μl, and the chromatogram is recorded. The results are shown in the table 1.

[0051] Table 1 System Suitability Test Results

[0052]

[0053] The test results show that the baseline is stable without interference, and the blank solvent has no interference with the detection of impurities and main components; the mixed control solution is continuously injected with 6 needles, neomycin (impurity A), neomycin sulfate B, neomycin sulfate C and sulfuric acid The RSD value of the retention time of paromomycin is 1.5, all meet the regulations, suitable for the inspection of related substanc...

Embodiment 3

[0085] The present embodiment provides a kind of detection method of neomycin sulfate component and related substances, chromatographic conditions:

[0086] Chromatographic column: ACE C18-PFP, 4.6*250mm, 3μm; flow rate: 0.6mL / min; column temperature, 30℃; concentration of the test solution: 0.5mg / ml; injection volume: 20μL; mobile phase A: 0.5 wt% trifluoroacetic acid aqueous solution, mobile phase B phase: methanol, mobile phase A and mobile phase B ratio is 90:10, drift tube temperature is 75°C, carrier gas pressure is 20Psi.

[0087] Precisely measure 20 μL each of the blank solvent, mixed solution, and test solution, inject them into the liquid chromatograph respectively, inject samples according to the above-mentioned high-performance liquid chromatography conditions, record the peak area of ​​each component and record the chromatogram, and the results are shown in Table 7.

[0088] Table 7 Test results of related substances in the test solution

[0089]

[0090] ...

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Abstract

The invention provides a method for detecting neomycin sulfate components and related substances. According to the invention, an HPLC-ELSD method is adopted for detection, and chromatographic conditions are as follows: a chromatographic column is ACE C18-PFP, 4.6 * 250 mm, 3 [mu] m; a mobile phase A is 0.1-5.0 wt% of trifluoroacetic acid aqueous solution, and a mobile phase B is methanol; the temperature of a drift tube is 30-100 DEG C, and the carrier gas pressure is 20-60 Psi. According to the detection method provided by the invention, neomycin sulfate components B and C, known impurities and a plurality of unknown impurities are effectively separated; through research and verification of specificity, sensitivity and other methodologies, it is found that the method is sensitive, accurate and high in reproducibility, more impurities in neomycin sulfate can be qualitatively and quantitatively detected through a simpler and more convenient method, and reliable guarantee is provided forimproving and better controlling the quality of neomycin sulfate products.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a detection method for neomycin sulfate components and related substances. Background technique [0002] Neomycin sulfate is the drug of choice for the treatment of bacterial enteritis in livestock and poultry. It is widely used in the treatment of mastitis, keratitis, conjunctivitis and other diseases in farmed animals. It can also be used as a feed additive to prevent premature damage and Enteritis, improve feed utilization, and promote the growth of livestock and poultry. [0003] Neomycin sulfate belongs to aminoglycoside antibiotics, and the main components of neomycin sulfate are neomycin sulfate B and neomycin sulfate C, and its degradation product is mainly neomycin (impurity A), which has serious ear, nephrotoxicity. At present, the detection methods of neomycin sulfate usually adopt microbial assay, pre-column derivatization method, HPLC-PAD, HPLC-CAD and ultra...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 李志伟郭宇鹏赵俊梅毕海超张寒李阳刘亚平孙威
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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