Development of a Validated Stability-Indicating LC Assay and Stress Degradation Studies of Linezolid in Tablets
Contribuinte(s) |
Universidade Estadual Paulista (UNESP) |
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Data(s) |
20/05/2014
20/05/2014
01/06/2009
|
Resumo |
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) 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. |
Formato |
129-135 |
Identificador |
http://dx.doi.org/10.1365/s10337-009-0993-3 Chromatographia. Wiesbaden: Vieweg, v. 69, p. 129-135, 2009. 0009-5893 http://hdl.handle.net/11449/7790 10.1365/s10337-009-0993-3 WOS:000267330400005 |
Idioma(s) |
eng |
Publicador |
Vieweg |
Relação |
Chromatographia |
Direitos |
closedAccess |
Palavras-Chave | #Column liquid chromatography #Validation #Linezolid |
Tipo |
info:eu-repo/semantics/article |