Development of a Validated Stability-Indicating LC Assay and Stress Degradation Studies of Linezolid in Tablets
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Data
2009-06-01
Autores
Lopes, Cristiani C. G. O. [UNESP]
Salgado, Hérida Regina Nunes [UNESP]
Título da Revista
ISSN da Revista
Título de Volume
Editor
Vieweg
Resumo
This paper describes the validation of an isocratic LC method for the assay of linezolid in tablets. Validation parameters such as linearity, precision, accuracy, specificity, limit of detection, limit of quantitation and robustness were determined. LC was carried out by reversed phase technique on an RP-18 column with a mobile phase composed of 1% acetic acid:methanol:acetonitrile (50:25:25, v/v/v). Linezolid and your combination drug product were exposed to acid, base, oxidation, dry heat and photolytic stress conditions. A linear response (r > 0.9999) was observed in the range of 8.0-20.0 mu g mL(-1). The retention time of linezolid was 4.6 min. The method showed good recoveries and intra- and inter-day relative standard deviations were less than 1.0%. The LOD and LOQ were 0.21 and 0.63 mu g mL(-1), respectively. The developed LC method for determination of related substances and assay determination of linezolid can be used to evaluate the quality of regular production samples. It can also be used to test the stability samples of linezolid.
Descrição
Palavras-chave
Column liquid chromatography, Validation, Linezolid
Como citar
Chromatographia. Wiesbaden: Vieweg, v. 69, p. 129-135, 2009.