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Detection method of Tildipirosin content

A technology of tediloxine and detection method, which is applied in the field of chemical analysis, can solve the problems of high difficulty, high requirements, and difficulty in quality control of tediloxine, and achieves the effects of accurate method, high sensitivity and good repeatability.

Inactive Publication Date: 2016-04-06
宁夏泰瑞制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no method recorded in the Pharmacopoeia for the detection of tedirosin content. The literature reports the residue analysis of tedirosin. The detection method used is solid phase extraction-mass spectrometry (SPE-HPLC-MS / MS). The method has high requirements and great difficulty, and it is difficult to carry out the quality control of Tideroxin in industrial production

Method used

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  • Detection method of Tildipirosin content
  • Detection method of Tildipirosin content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Preparation of new samples of tedrol:

[0022] Preparation of the standard solution: Weigh 50 mg of Tedirosin standard, weigh it accurately, put it in a 50ml volumetric flask, add mobile phase to dissolve and set the volume to the mark, and shake well. Take the solution with a 1ml syringe and filter it through a 0.45um organic filter head to obtain a standard solution.

[0023] Preparation of the test solution: Weigh 50 mg of Tedirosin sample, accurately weigh it, place it in a 50 ml volumetric flask, add an appropriate amount of mobile phase, dissolve it and set the volume to the mark, and shake well. Take the solution with a 1ml syringe and filter it through a 0.45um organic filter head to obtain the test solution.

[0024] Five copies of each of the standard solution and the test solution were prepared.

[0025] Chromatographic analysis conditions:

[0026] Shimadzu LC-20A liquid chromatograph, WatersC18 column (250*4.6, 5um);

[0027] Mobile phase: methanol: ace...

Embodiment 2

[0049] Samples and standard preparations are the same as in Example 1.

[0050] Chromatographic analysis conditions:

[0051] Shimadzu LC-20A liquid chromatograph, WatersC8 column (150*4.6, 3.5um);

[0052] Mobile phase: methanol: acetonitrile: 0.05mog / L potassium dihydrogen phosphate solution (pH6.50) = (40:25:35);

[0053] Flow rate: 0.8ml / min;

[0054] Detection wavelength: 290nm;

[0055] Injection volume: 20ul;

[0056] Detector: UV detector;

[0057] Column oven: 30°C.

[0058] According to the above-mentioned chromatographic conditions, inject samples respectively to all standard substances and test substances, such as figure 1 As shown, the peak area obtained by injecting 5 samples of the standard solution respectively was 12545262, and the RSD was 0.21%; the average value of the peak area obtained by the 5 samples of the test solution was 10201259, and the RSD was 0.22%.

[0059] According to the formula:

[0060] The content of tadiroxin: a=A sample M standar...

Embodiment 3

[0063] Samples and standard preparations are the same as in Example 1.

[0064] Chromatographic analysis conditions: Shimadzu LC-20A liquid chromatograph, WatersC8 chromatographic column (150*4.6, 3.5um);

[0065] Mobile phase: methanol: acetonitrile: 0.05mog / L potassium dihydrogen phosphate solution (pH7.50) = (40:30:40);

[0066] Flow rate: 1.2ml / min;

[0067] Detection wavelength: 270nm;

[0068] Injection volume: 10ul;

[0069] Detector: UV detector;

[0070] Column oven: 40°C.

[0071] According to the above-mentioned chromatographic conditions, inject samples respectively to all standard substances and test substances, such as figure 1 As shown, the peak area obtained by injecting 5 samples of the standard solution was 12135495 respectively, and the RSD was 0.10%; the average value of the peak area obtained by the 5 samples of the test solution was 10594411, and the RSD was 0.09%.

[0072] According to the formula:

[0073] The content of tadiroxin: a=A sample M sta...

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Abstract

The present invention relates to a detection method of Tildipirosin content. The detection method uses high performance liquid chromatography to determine the content, and then the Tildipirosin content is calculated by an external standard method. The present invention uses high performance liquid chromatography to determine the content of Tildipirosin, and then the external standard method is used to quantify the content of Tildipirosin in sample. The method is accurate and simple, and has good reproducibility and high sensitivity. When Tildipirosin is between 0.1mg / ml-3.0mg / ml, good linear relationship exists, and the correlation coefficient is 0.9995. Through verification, the method is applicable to quality control and detection of Tildipirosin in veterinary drugs business.

Description

technical field [0001] The invention belongs to the technical field of chemical analysis, and in particular relates to a method for detecting the content of tediroxin. Background technique [0002] Tildipirosin (Tildipirosin) is the latest semi-synthetic antibiotic of animal-specific macrolides developed abroad. It is a derivative of Tylosin. On March 8, 2011, it was approved by the EU Veterinary Medicines Committee (CVMP) The market license for the sterile injection drug (trade name: Zuprero) of Intervet with the main component of Tedirosin. Subsequently, it will be approved for marketing in EU countries one after another. The new CAS number of Tedilol is 328898-40-4, and the molecular formula is C 41 h 71 N 3 o 8 , with a melting point of 192°C, soluble in polar organic solvents (such as acetone, methanol, etc.), slightly soluble in water, and its structural formula is as follows: [0003] [0004] At present, there is no method recorded in the Pharmacopoeia for t...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 陈红丽
Owner 宁夏泰瑞制药股份有限公司
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