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Method for detecting content of gamithromycin

A technology of gamiycin and detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of no uniform standard for drugs, no detection and analysis methods for chemical drugs, hindering the application and promotion of drugs, etc.

Inactive Publication Date: 2014-04-09
挑战(天津)动物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] However, in the process of developing gamithromycin, there is no ready-made detection and analysis method for this chemical drug. This situation makes the drug no uniform standard, which greatly hinders the application and promotion of the drug

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  • Method for detecting content of gamithromycin
  • Method for detecting content of gamithromycin
  • Method for detecting content of gamithromycin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] ⅠInstrument equipment and raw materials:

[0021] Agilent 1260 liquid chromatograph, equipped with DAD diode array detector, OPENLAB chromatography workstation, C 8 、C 18 Chromatographic column;

[0022] Acetonitrile (HPLC grade), dipotassium hydrogen phosphate (analytical grade), secondary deionized water, gamimycin reference substance (provided by China Institute for the Control of Pharmaceutical and Biological Products), gamithromycin (commercially available).

[0023] ⅡPreparation of sample for Gamithromycin analysis:

[0024] 1. Weigh 0.01021g gamithromycin into a 10ml volumetric flask, add 2ml acetonitrile to dissolve, dilute to the mark with mobile phase, and shake well.

[0025] 2. Accurately weigh 10.02㎎ of Gamithromycin reference substance into a 10ml volumetric flask, add 2ml of acetonitrile to dissolve, dilute to the mark with mobile phase, and shake well.

[0026] 3. Chromatographic analysis conditions:

[0027] Mobile phase: acetonitrile: 0.025mol / ml ...

Embodiment 2

[0033] ⅠInstrument equipment and raw materials:

[0034] Agilent 1260 liquid chromatograph, equipped with DAD diode array detector, OPENLAB chromatography workstation, C 8 、C 18 Chromatographic column;

[0035] Acetonitrile (HPLC grade), dipotassium hydrogen phosphate (analytical grade), secondary deionized water, gamimycin reference substance (provided by China Institute for the Control of Pharmaceutical and Biological Products), gamimycin injection (commercially available, specification 15g : 100ml).

[0036] ⅡPreparation of sample for Gamithromycin analysis:

[0037] 1. Pipette 1ml of Gamithycin Injection into a 10ml volumetric flask, dilute to the mark with mobile phase, and shake well; gradually dilute the solution to 1㎎ / ml with an appropriate amount of mobile phase, and filter the resulting solution with a microporous membrane.

[0038] 2. Accurately weigh 10.15㎎ of Gamithycin reference substance into a 10ml volumetric flask, add 1-2ml of acetonitrile to dissolve, di...

Embodiment 3

[0046] ⅠInstrument equipment and raw materials:

[0047] Agilent 1260 liquid chromatograph, equipped with DAD diode array detector, OPENLAB chromatography workstation, C 8 、C 18 Chromatographic column;

[0048] Acetonitrile (HPLC grade), dipotassium hydrogen phosphate (analytical grade), secondary deionized water, gamimycin reference substance (provided by China Institute for the Control of Pharmaceutical and Biological Products), gamimycin premix (commercially available, specifications 15g: 100g).

[0049] ⅡPreparation of sample for Gamithromycin analysis:

[0050] 1. Pipette 1.04g of Gamithycin Premix into a 10ml volumetric flask, dilute to the mark with mobile phase, shake well, gradually dilute the solution to 1㎎ / ml with an appropriate amount of mobile phase, and filter the resulting solution with a microporous membrane .

[0051] 2. Accurately weigh 10.11㎎ of Gamithromycin reference substance into a 10ml volumetric flask, add 1-2ml of acetonitrile to dissolve, dilute...

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Abstract

The invention provides a method for detecting the content of gamithromycin. The method comprises the steps: dissolving a gamithromycin sample to be detected by a flowing phase, and performing liquid phase chromatogram quantitative analysis by using a DAD (Dioxide Array Detector) detector adopting C8 and C18 chromatographic columns, wherein chromatographic conditions are as follows: the flowing phase is as follows: a weight ratio of acetonitrile to 0.025mol / ml dipotassium phosphate solution (PH8-8.5) is 70:30, a flow velocity is 1.00-2.00ml / min, and a detection wavelength is 210-230nm. The method is accurate and simple, and is good in reproducibility and high in sensitivity.

Description

technical field [0001] The invention relates to a drug content detection method, in particular to a gamithromycin content detection method. Background technique [0002] Gamithromycin belongs to macrolide antibiotics and is mainly used for the treatment of cattle infectious diseases caused by bacterial pathogens such as Pasteurella hemolytica, Pasteurella multocida and histophilia. , wide distribution in the body, low residual amount, high safety, etc., and no adverse reaction reports, it has broad application prospects in veterinary clinics. [0003] The synthetic route of gamithromycin is as follows: [0004] [0005] However, in the process of developing gamithromycin, there is no ready-made detection and analysis method for this chemical drug. This situation makes this drug no uniform standard, which greatly hinders the application and promotion of this drug. Therefore, it is very necessary to establish an effective and stable content detection method. Contents of...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 姜淋洁王猛程雪娇余贵菊焦晓军
Owner 挑战(天津)动物药业有限公司
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