Validation of a stability-indicating RP-LC method for the determination of tigecycline in lyophilized powder
Nenhuma Miniatura disponível
Data
2013-02-01
Autores
Da Silva, Lucélia Magalhães [UNESP]
Salgado, Hérida Regina Nunes [UNESP]
Título da Revista
ISSN da Revista
Título de Volume
Editor
Resumo
A reversed-phase liquid chromatography (RP-LC) method was validated for the determination of tigecycline in lyophilized powder. The LC method was conducted on a Luna C18 column (250 × 4.6 mm i.d.), maintained at room temperature. The mobile phase consisted of buffer containing sodium phosphate monobasic (0.015M) and oxalic acid (0.015M) (pH 7.0)-acetonitrile (75:25, v/v), run at a flow rate of 1.0 mL/min and using ultraviolet detection at 280 nm. The chromatographic separation was obtained with a retention time of 8.6 min, and was linear in the range of 40-100 μg/mL (r2 = 0.9997). The specificity and stability-indicating capability of the method was proven through forced degradation studies, which also showed no interference of the excipients. The accuracy was 99.01% with a bias lower than 1.81%. The limits of detection and quantitation were 1.67 and 5.05 μg/mL, respectively. Moreover, method validation demonstrated satisfactory results for precision and robustness. The proposed method was applied for the analysis of the lyophilized powder formulation, contributing to improve the quality control and to assure the therapeutic efficacy. © The Author [2012]. Published by Oxford University Press. All rights reserved.
Descrição
Palavras-chave
drug derivative, minocycline, tigecycline, chemistry, drug stability, limit of detection, methodology, powder, reproducibility, reversed phase liquid chromatography, standard, statistical model, Chromatography, Reverse-Phase, Drug Stability, Limit of Detection, Linear Models, Minocycline, Powders, Reproducibility of Results
Como citar
Journal of Chromatographic Science, v. 51, n. 2, p. 192-199, 2013.