Rapid turbidimetric assay to potency evaluation of tigecycline in lyophilized powder

Autor(es)

da Silva, Lucelia Magalhaes ^[1] ; Nunes Salgado, Herida Regina ^[2]

Afiliação do(s) autor(es)

^[1] Univ Fed Alfenas UNIFAL, BR-37130000 Alfenas, MG - Brazil

^[2] UNESP, Fac Ciencias Farmaceut Araraquara, Araraquara, SP - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Journal of Microbiological Methods; v. 110, p. 49-53, MAR 2015.
• Citações Web of Science: 2

Resumo

Tigecycline, a first-in-class glycylcycline and an analog of the semisynthetic antibiotic minocycline, is a potent, broad-spectrum antibiotic that acts by the inhibition of protein translation in bacteria. This glycylcycline inhibits Gram-positive, Gram-negative, atypical, anaerobic and antibiotic-resistant organisms. There is no microbiological analytical method for tigecycline in lyophilized powder reported yet. Thus, this paper reports the development and validation of a simple, sensitive, accurate and reproducible turbidimetric method to quantify tigecycline in lyophilized powder, using Staphylococcus aureus as microorganism test and 3 x 3 parallel line assay design, with twenty tubes for each assay. The validated method showed good results of linearity in the concentration range from 3 to 432 mu g/mL (r(2) = 0.9999), selectivity, precision, robustness and accuracy of 99.74%. The results demonstrated the validity of the proposed bioassay, which allows reliable quantitation of tigecydine in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine. (C) 2015 Elsevier B.V. All rights reserved. (AU)

• Processo FAPESP: 09/53434-2 - Desenvolvimento e validação de metodologia analítica e estudo de estabilidade de tigeciclina em produto farmacêutico
• Beneficiário: Lucelia Magalhaes da Silva
• Modalidade de apoio: Bolsas no Brasil - Doutorado