Validation of microbiological method cylinder plate for the determination of antimicrobial potency of gentamicin in a veterinary injectable pharmaceutical product.

Abstract

The pharmaceutical industry focuses on the development and distribution of medications through the research and development of new drugs, emphasizing innovation and the minimization of side effects. However, these advancements face scientific, social, and economic challenges, along with quality regulations. The objective of this research was to determine the antimicrobial potency of an injectable pharmaceutical product with gentamicin as the active ingredient using the Cylinder Plate method, as well as to design and validate the methodology. The methodology used references the general analysis method, microbiological evaluation of antibiotics from the Mexican Pharmacopoeia. This demonstrates that the veterinary injectable pharmaceutical product with a net content of 100 mL, where 20% corresponds to Gentamicin as the active ingredient, achieved an antimicrobial potency of 95.83%, thus inhibiting the growth of the test microorganism, Staphylococcus epidermidis. By implementing this validated method, the reliability of the results is ensured.