Quantification and Determination of Stability of Tylvalosin in Pig Plasma by Ultra-High Liquid Chromatography with Ultraviolet Detection

SIMPLE SUMMARY: Tylvalosin (TV) is a third-generation macrolide antibiotic, registered exclusively for veterinary medicine to treat respiratory and enteric bacterial infections in swine and poultry. In the coming years, the use of this drug will probably be widely studied in different species. However, before its use in each veterinary species, macrolide analytical determination in various biological fluids is a pre-requisite step for the rational dose calculation of TV based on specific pharmacokinetic information. Its quantification is essential to detect and avoid the appearance of residues in animal products intended for human consumption. Therefore, the aim of this proposed method was to develop a high-performance liquid chromatography (HPLC) method with ultraviolet detection for TV quantification in pig plasma. According to the food and drug administration (FDA) guidelines, this quick, sensitive, and reproducible validated method produced a good performance. This method can be useful for storing plasma samples for months and for performing routine analysis and pharmacokinetic studies. ABSTRACT: Tylvalosin (TV) is a macrolide antibiotic that is used for treating respiratory and enteric bacterial infections in swine and in poultry. In the coming years, the use of this drug will probably be widely studied in different species, but before its use in each veterinary species, macrolide analytical determination in various biological fluids is a pre-requisite step for the rational dose calculation of TV based on specific pharmacokinetic information. Its quantification is essential for detecting and avoiding the appearance of residues in animal products intended for human consumption. Therefore, a robust chromatographic method coupled with an ultraviolet detector was fully validated for the quantification of TV in pig plasma. A mixture (78:22) of (A) 0.3% formic acid in water and (B) acetonitrile was used as the mobile phase. TV and enrofloxacin (internal standard) were eluted at 14.1 and 5.9 min, respectively. Calibration curves ranged from 0.1 to 5 μg/mL. The accuracy and precision parameters for the quality controls were always <13.0%. Recovery ranged from 89.66 to 96.92%. The detection and quantification limits were found to be 0.05 μg/mL and 0.1 μg/mL, respectively. This method could be applied to develop pharmacokinetic studies.