title: Rapid turbidimetric assay to potency evaluation of tigecycline in lyophilized powder.
abstract: 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 3×3 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 4.32μg/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 tigecycline in pharmaceutical samples and therefore can be used as a useful alternative methodology for the routine quality control of this medicine.
authors.affiliation: Universidade Federal de Alfenas - UNIFAL, Alfenas, MG, Brazil. Electronic address: lucmsil@yahoo.com.br.
authors.forename: Lucélia Magalhães
authors.initials: LM
authors.lastname: da Silva
authors.affiliation: Faculdade de Ciências Farmacêuticas de Araraquara - UNESP, Araraquara, SP, Brazil.
authors.forename: Hérida Regina Nunes
authors.initials: HR
authors.lastname: Salgado
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis* / Q000494:pharmacology; D001681:Biological Assay / Q000379:methods; D002851:Chromatography, High Pressure Liquid; D005612:Freeze Drying; D008826:Microbial Sensitivity Tests; D008911:Minocycline / Q000031:analogs & derivatives* / Q000032:analysis / Q000494:pharmacology; D009391:Nephelometry and Turbidimetry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013211:Staphylococcus aureus / Q000187:drug effects*; D000078304:Tigecycline
chemical_list: D000900:Anti-Bacterial Agents; D000078304:Tigecycline; D008911:Minocycline
keywords: Quality control; Tigecycline; Turbidimetric assay