Tildipirosin content determining method

Abstract

The invention discloses a tildipirosin content determining method. The method is an HPLC (high performance liquid chromatography) method, an Agilent Zorbax SB-C18 5mu m 4 .6*250mm chromatographic column is adopted; 0.3% trifluoroacetic acid and phosphate buffer-acetonitrile in the volume ratio being 70-75:25-30 is taken as a mobile phase, and pH of the buffer is regulated to 2.5 by triethylamine;determining wavelength is 270-290 nm; column temperature is 30-40 DEG C; flow rate is 0.8 -1.2 ml / min; a sample is quantified according to the sum of areas of a main peak and an isomer peak with an external standard method. The mobile phase system is stable, and determining data is reliable; the method is good in specificity, reproducibility, precision, linearity and accuracy; an isomer can be detected accurately under the chromatographic conditions, and the main peak and the isomer peak can be separated effectively.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting the content of tedirosin. Background technique [0002] Tedirosin is a new type of animal-specific macrolide antibiotics, the molecular formula is C 41 h 71 N 3 o 8 , the molecular weight is 734.02, and the chemical name is (4R, 5S, 6S, 7R, 9R, 11E, 13E, 15R, 16R)-16-ethyl-4-hydroxyl-5,9,13-trimethyl-7-[ 2-(1-piperidinyl)ethyl]-15-[(1-piperidinyl)methyl]-6-{[3,6-dideoxy-4-hydroxyl-3-(dimethylamino) -β-D-glucopyranosyl]oxy}oxycyclohexadeca-11,13-diene-2,10-dione. The structural formula is: [0003] [0004] At present, domestic macrolide drugs used to prevent and treat porcine respiratory diseases mainly include tylosin and tilmicosin, which are usually administered in the form of mixing materials and drinking water, with low oral bioavailability and use. The cycle is long, and as time goes on, drug resistance gradually increases. Tedirosin ...

AI Technical Summary

Problems solved by technology

The chromatographic system chooses a high-concentration buffer salt system combined with an organic phase, which is prone to salting out of the mobile phase, causing blockage and failure of expensive inspection equipment such as high-performance liquid chromatography and chromatographic columns, and reducing the service life of chromatographic columns.

[0007] In addition, neither of the above two patent documents requires dark operation, and Tedirosin is unstable to light, especially in the solution state

Therefore, under normal conditions, the accuracy of the obtained data is not high

[0008] In the research, it was found that there are isomers of Tideroloxin, which were not given in the above two patent documents, no isomer chromatographic peaks were detected in the detection spectrum, and there was no separation data between the main peak and the isomer chromatographic peaks

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