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Method for detecting gamithromycin content

A detection method, gamimycin technology, applied in the detection field of gaminomycin content, can solve the problems of high price, low sensitivity and precision, inconvenient operation, etc., and achieve simple method, good repeatability and easy operation Effect

Inactive Publication Date: 2018-01-26
华北制药集团动物保健品有限责任公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The purpose of the present invention is to provide a detection method of gamimycin content, to solve the problems of high price, inconvenient operation, low sensitivity and precision of existing detection methods

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1: Detection of the content of gamimycin injection.

[0058] 1) Chromatographic conditions

[0059] Octadecylsilane bonded silica gel is used as the filler, and the selected specifications are: C18 chromatographic column with a length of 250mm, an inner diameter of 4.6mm, and a filler particle size of 5μm; , adjust pH to 8.0 with 20% phosphoric acid solution)-acetonitrile (20:80) is mobile phase; Flow rate is 1.0mL / min; Detection wavelength is 210nm; Column temperature is 40 ℃; Autosampler injection volume is 20 μ L.

[0060] Blank solvent interference test

[0061] Precisely measure 20 μL each of the blank solvent (i.e. acetonitrile) and gaminomycin reference substance solution (precisely weighed gaminomycin reference substance, and add acetonitrile to make a solution containing about 0.3 mg per 1 mL), and inject them into the liquid chromatograph. To record the chromatogram, see figure 1 , the results show that under this method, the blank solvent has no...

Embodiment 2

[0087] Example 2: Detection of the content of the original drug of gamithromycin.

[0088] 1) Chromatographic conditions: with embodiment 1.

[0089] 2) Drawing of standard curve: with embodiment 1.

[0090] 3) Detect the content of the original drug of gamithromycin to be tested

[0091] Accurately weigh the original drug of gamimycin to be tested (approximately equivalent to 30mg gamimycin), put it in a 100mL measuring bottle, dissolve it with acetonitrile and dilute to the mark, shake well, and get it, take 20μL and inject it into the liquid chromatograph , record the chromatogram as Figure 7 ; Take another appropriate amount of Gamithromycin reference substance, accurately weighed, add acetonitrile to make a solution containing about 0.3mg per 1mL, and determine with the same method. According to the external standard method to calculate the peak area, that is. The calculation method of gamithromycin content is calculated according to 1. formula of step (4) in the spe...

Embodiment 3

[0107] 1) Chromatographic conditions

[0108] Octadecylsilane bonded silica gel is used as filler, and the specification of C18 chromatographic column is: length 250mm, inner diameter 4.6mm, filler particle diameter 5μm; Use 20% phosphoric acid solution to adjust the pH to 7.8)-acetonitrile (30:70) as the mobile phase; the flow rate is 0.8mL / min; the detection wavelength is 210nm; the column temperature is 35°C. The injection volume of the autosampler was 20 μL.

[0109] 2) standard curve drawing: with embodiment 1.

[0110] 3) Detecting the content of the Gamithromycin injection to be tested: Same as in Example 1, the Gamithromycin content is 99.88% of the indicated content.

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Abstract

The invention provides a method for detecting the gamithromycin content. The method is high performance liquid chromatography, a C18 chromatographic column is used to enforce separation, a UV detectoris used to carry out quantitative analysis, and chromatographic conditions are as follows: the mobile phase comprises a dipotassium hydrogen phosphate solution with the pH value being 7.8-8.2 and theconcentration being 0.01 mol / L and 60-80% (v / v) of acetonitrile; the flow velocity is 0.8-1.2 mL / min; the column temperature is 35-45 DEG C; and the detection wavelength is 210 nm. The composition, the kind, the concentration and the ratio of the mobile phase are selected in the method to reach a high sensitivity and a high separation degree by using the UV detector, so the problems of high priceand use convenience, brought by selection of an evaporative light-scattering detector for improving the sensitivity and the separation effect in the prior art, are solved. The method has the advantages of simplicity, easiness in operation, accurate and reliable result, high sensitivity, good reappearance, high separation degree, low cost, cheap and easily available device and reagents, and convenience in promotion and application.

Description

technical field [0001] The invention relates to a method for detecting drug content, in particular to a method for detecting gaminomycin content. Background technique [0002] Gamithromycin (English name Gamithromycin, molecular formula: C 40 h 76 N 2 o 12 , molecular weight: 777.04) is white or off-white crystalline powder, odorless, bitter in taste, slightly hygroscopic, easily soluble in chloroform, soluble in methanol, dilute hydrochloric acid, soluble in ethanol, soluble in acetonitrile Slightly soluble in medium, almost insoluble in water. [0003] Gamimycin is a semi-synthetic azamacrolide veterinary antibiotic with a 15-membered ring. It mainly binds to the 50S subunit of the bacterial ribosome to prevent the extension of the polypeptide chain, thereby inhibiting the synthesis of bacterial proteins. In vitro test data show that gamithromycin has inhibitory effects on Mannella hemolyticus, Pasteurella multocida, Actinomyces pleuropneumoniae, Haemophilus parasuis,...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 邓菲康彦陈清平杨琳王艳艳段鹏黄月辉任艳张云茜
Owner 华北制药集团动物保健品有限责任公司
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