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Method for determining gamithromycin related substances

Pending Publication Date: 2022-08-09
ZHEJIANG GUOBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, gamithromycin is not included in the "Chinese Veterinary Pharmacopoeia" and the publicly issued national standards for veterinary drugs, nor is it included in the US Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia and other pharmacopoeias, which brings certain difficulties to the research work

Method used

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  • Method for determining gamithromycin related substances
  • Method for determining gamithromycin related substances
  • Method for determining gamithromycin related substances

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Instruments: high performance liquid chromatography, Agilent 1260; electronic balance, Mettler XSR 105; pH meter, Mettler FE28.

[0037] Reagents: disodium hydrogen phosphate dodecahydrate (analytical grade), Sinopharm; ammonia water (analytical grade), Sinopharm; acetonitrile (chromatographic grade).

[0038] Chromatographic conditions: chromatographic column Waters Xterra RP18 (4.6mm×15cm, 3.5μm); flow rate 1.0ml / min; detection wavelength 210nm; injection volume 20μL; column temperature 50°C; injector condensation temperature 4°C.

[0039] Mobile phase A: 2.8mmol / L dodecahydrate disodium hydrogen phosphate solution: acetonitrile=85:15 (v / v), adjust pH=10.5 with ammonia water; mobile phase B: 80% acetonitrile aqueous solution; dissolving solution 65% acetonitrile aqueous solution .

[0040] Gradient elution was performed according to the procedure shown in Table 1.

[0041] Table 1: Gradient elution program table

[0042] time, min 0 2 18 35 40 55 56...

Embodiment 2

[0080] Chromatographic conditions: flow rate 0.9 ml / min, other chromatographic conditions are the same as in Example 1.

[0081] Take 20 μL of the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram.

[0082] The detection results of related substances in the system suitability solution are shown in Table 10, and the obtained HPLC chromatogram is shown in Table 10. image 3 , it can be seen from Table 10 that all impurity peaks are effectively separated, and the main peak is completely separated from the adjacent impurity peaks.

[0083] Table 10: System Suitability Solution Related Substance Test Results

[0084]

[0085]

Embodiment 3

[0087] Chromatographic conditions: the flow rate was 1.1 ml / min, and other chromatographic conditions were the same as those in Example 1. .

[0088] Take 20 μL of the system suitability solution, inject it into the liquid chromatograph, and record the chromatogram.

[0089] The detection results of related substances in the system suitability solution are shown in Table 11, and the obtained HPLC chromatogram is shown in Table 11. Figure 4 , it can be seen from Table 11 that all impurity peaks are effectively separated, and the main peak is completely separated from the adjacent impurity peaks.

[0090] Table 11: System Suitability Solution Related Substance Test Results

[0091]

[0092]

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Abstract

The invention provides a method for determining gamithromycin related substances, and belongs to the technical field of column chromatography test or analysis materials. The gamithromycin related substances refer to impurities introduced in a gamithromycin synthesis process or generated by degradation. The method is applied to determination of gamithromycin related substances, and has the advantages of stable chromatographic condition system, good linearity, high precision, high chromatographic condition sensitivity, good specificity, stable determination solution within 35 h, and the like.

Description

technical field [0001] The application relates to a related substance of gamitomycin and a determination method thereof, and belongs to the technical field of drug impurity detection and analysis. Background technique [0002] Gamithromycin (English name Gamithromycin, molecular formula: C 40 H 76 N 2 O 12 , molecular weight: 777.04) is a white to off-white crystalline powder, easily soluble in dichloromethane, soluble in ethanol, and almost insoluble in water. [0003] Gamycin is a new type of semi-synthetic MALs (macrolide antibiotics) veterinary antibiotics, which play a bactericidal effect by inhibiting the RNA-dependent protein synthesis of sensitive bacteria. The drug was approved by the European Medicines Agency (EMA), the Canadian Health Products and Food Administration (HPFB), and the U.S. Food and Drug Administration (FDA) in 2007, 2010 and 2011, respectively, for the prevention and treatment of Pasteurella immitis, Mycoplasma , Bovine Respiratory Disease (BRD...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86B01J20/281
CPCG01N30/02G01N30/30G01N30/32G01N30/34G01N30/74G01N30/8679G01N2030/027G01N2030/3007G01N2030/324G01N2030/342
Inventor 胡德行吴娇周志奎朱庆国单继雷夏文文徐华杰李开莹臧浩景秦欣荣姚礼高邱家军
Owner ZHEJIANG GUOBANG PHARMA
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