Abstract

Simple Summary In this study, two analytical methodologies were developed for the analysis of florfenicol and oxytetracycline premixes, which were applied in the analysis of pharmaceutical formulations manufactured at the national level. These premixes were assessed, since florfenicol and oxytetracycline are widely used in poultry farming, as they are active against several types of bacteria and their cost/effectiveness ratio is quite attractive and are administered for the therapeutic treatment of bacterial infections. However, these premixes must actually contain the active ingredients at a concentration that matches what the manufacturer states on their labels. Otherwise, they will not reach plasma concentrations that are therapeutically effective. In this work we set forth to verify via LC-MS/MS whether three commercial formulations of oxytetracycline premixes, and two of florfenicol, effectively matched their labels or not. Interestingly, this methodology detected oxytetracycline at a higher concentration than expected for those formulations, whereas the concentrations of florfenicol were lower than the on-label statement for both formulations. Antimicrobials premixes are the presentation of choice to administer drugs simultaneously to groups of animals in intensive husbandry systems that require treatment for pathologies of bacterial origin. Among the premixes available for use in poultry, florfenicol and oxytetracycline are commonly administered via food or water. However, their actual concentration in premixes must meet on-label statements to ensure plasma concentrations reach effective therapeutic levels. Hence, this work was designed for the purpose of verifying whether the concentration of antimicrobial present in five premixes matched their on-label statement. Three oxytetracycline premixes, and two of florfenicol, were analysed using a Xevo TQ-S micro UPLC-MS/MS, and an ABSciex API4000 HPLC-MS/MS, respectively. Analytical methodologies were implemented and validated, showing an R-2 >= 0.99 for the calibration curves. Oxytetracycline was detected in these premixes at concentrations exceeding on-label statements by 13.28%, 21.54%, and 29.68%, whereas florfenicol concentrations detected in premixes were 13.06% and 14.75% lower than expected. Consequently, this work shows that the concentration of active ingredients that are present in commercial formulations effectively differ from those stated on premix labels, and it also highlights how unpredictable their range of variability might be. This must be addressed through solid and updated laws that guarantee an effective pharmaceutical product.