Method for detecting content of tildipirosin

A new detection method technology of Tidelot, which is applied in the field of analysis, can solve the problems of low sensitivity and achieve the effects of good repeatability, good precision and good linear relationship

Inactive Publication Date: 2020-03-06
河北远征药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved in the present invention is to provide a detection method for the new content of tedrol, the method provides a basis for the detection of the content of the new preparation of tedrol, and solves the problem of low sensitivity of the existing detection method

Method used

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  • Method for detecting content of tildipirosin
  • Method for detecting content of tildipirosin
  • Method for detecting content of tildipirosin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Embodiment 1: Tediroxin injection content determination

[0054] Chromatographic conditions: CAPCELL PAK C18 250×4.6mm, 5μm C18 chromatographic column; mobile phase 0.1% trifluoroacetic acid-acetonitrile (18:82V / V); detection wavelength: 285nm; column temperature 30°C; flow rate: 1.0ml / min; autosampler injection volume: 10 μl.

[0055] Preparation of the reference solution: Take about 50 mg of Tedirosin reference substance, weigh it accurately, put it in a 50ml brown measuring bottle, add 2ml of acetonitrile to dissolve, dilute to the mark with mobile phase, shake well; take 1ml precisely, put it in 10ml brown In a measuring bottle, dilute to the mark with mobile phase, shake well, and use it as a reference solution;

[0056] Test product solution for Tedirosin injection: Take an appropriate amount of Tedirosin injection (approximately equivalent to 10 mg Tedirosin) and place it in a 10ml brown measuring bottle, dissolve it with mobile phase to make it volume, and sha...

Embodiment 2

[0081] Embodiment 2: Tediroxin original drug content detection

[0082] 1) Chromatographic conditions: CAPCELL PAK C18 250×4.6mm, 5μm C18 chromatographic column; mobile phase 0.1% trifluoroacetic acid-acetonitrile (18:82V / V); detection wavelength: 285nm; column temperature 30°C; flow rate: 1.0 ml / min; autosampler injection volume: 10μl.

[0083] Preparation of the reference solution: Take about 50 mg of Tedirosin reference substance, weigh it accurately, put it in a 50ml brown measuring bottle, add 2ml of acetonitrile to dissolve, dilute to the mark with mobile phase, shake well; take 1ml precisely, put it in 10ml brown In a measuring bottle, dilute to the mark with mobile phase, shake well, and use it as a reference solution;

[0084] The preparation of Tedirosin original drug test solution: get an appropriate amount of Tedirosin original drug (about 50 mg Tedirosin), accurately weighed, put in a 50ml brown measuring bottle, add acetonitrile 2ml to dissolve, and dilute to s...

Embodiment 3

[0102] 1) Chromatographic conditions: CAPCELL PAK C18 250×4.6mm, 5μm C18 chromatographic column; mobile phase 0.1% trifluoroacetic acid-acetonitrile (20:80V / V); detection wavelength: 285nm; column temperature 25°C; flow rate: 0.8ml / min; injection volume: 10 μl.

[0103] 2) Drawing of standard curve: with embodiment 1.

[0104] 3) The content of Tedirosin injection to be tested: the same as that in Example 1, Tedirosin is the labeled content of 99.61%.

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Abstract

The invention discloses a method for determining the content of tildipirosin. The method uses a high-performance liquid chromatography for analysis and an external standard method for quantification.Octadecyl silane is used as a chromatographic column, determining is carried out at a wavelength of 285 nm, and through verification, the method has the characteristics of high sensitivity, good repeatability and high accuracy. The limit of quantification is 0.34 [mu]g / ml, the limit of detection is 0.113 [mu]g / ml, the linear relationship is good in the concentration range of 0.34-150 [mu]g / mL, wherein R<2>=0.9997. The method can be used for effectively detecting tildipirosin and is an accurate and efficient determination method.

Description

technical field [0001] The invention belongs to the technical field of analysis, and in particular relates to a method for detecting the content of tedirosin. Background technique [0002] Tildipirosin is a semi-synthetic macrolide antibiotic for animals developed by Intervet-Schering-Plough, and it is a derivative of tylosin. The mechanism of action is the same as that of other macrolides. It can bind to the ribosome 50s subunit of sensitive bacteria, hinder the synthesis and elongation of peptide chains, and affect the synthesis of bacterial proteins. Tedirosin is a broad-spectrum antibacterial drug, which has antibacterial activity against some Gram-positive and Gram-negative bacteria, and is particularly sensitive to pathogenic bacteria that cause respiratory diseases in pigs and cattle, such as Actinobacillus pleuropneumoniae, multocida Pasteurella, Bordetella bronchiseptica, Haemophilus parasuis, Mannella hemolyticus, Histophilus somniferus, etc. Tediroxin is more ef...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/047
Inventor 郭李珉刘静宋婷婷李红园郭鸿志吕让耿智霞贾兴瞿红颖田俊岭郭建立张玉
Owner 河北远征药业有限公司
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