Determination of Residual Solvents in Acetylisovaleryltylosin Tartrate Based on Computer Chromatography

Abstract

Acetylisovaleryltylosin Tartrate is a kind of macrolide antibiotic used for mycoplasma infection in pigs and chickens. The 2017 edition of “Quality Standard for Veterinary Drugs” clearly stipulates the characteristics, identification, inspection and content determination of Acetylisovaleryltylosin Tartrate. In this paper, firstly, the framework of computer chromatography and method verification are introduced. And then computer chromatography is applied to the determination of residual solvents in Acetylisovaleryltylosin Tartrate to process and analyze the output chromatographic data, and to determine the type and quantity of residual solvents. Finally, the determination of residual solvents in Acetylisovaleryltylosin Tartrate is actually analyzed. The residues of ethanol, acetone, dichloromethane, toluene, butyl acetate, and N-N dimethylformamide are determined by computer chromatography. The method is simple and has high column efficiency with accurate and reliable results, which meets the limit requirements of Pharmacopoeia. The chromatographic conditions and solution configuration in the residual solvent of Acetylisovaleryltylosin Tartrate are used to carry out a systematic applicability test to judge whether the blank solvent interferes with the reference substances of six residual solvents. In addition, the residual solvents in Acetylisovaleryltylosin Tartrate are analyzed before the test. Then computer gas chromatography is used to determine the six residual solvents in Acetylisovaleryltylosin Tartrate. The final result is that all six residual solvents meet the specified limits.