Oliveira Paulo R, Bernardi Larissa S, Mendes Cassiana, Cardoso Simone G, Sangoi Maximiliano A S, Silva Marcos R
Department of Pharmaceutical Sciences, Health Science Centre, Federal University of Santa Catarina, 88040-900, Florianópolis-SC, Brazil.
J Chromatogr Sci. 2009 Oct;47(9):739-44. doi: 10.1093/chromsci/47.9.739.
A stability indicating reversed-phase liquid chromatography method is developed and validated for the determination of norfloxacin in a new formulation of extended-release tablets. The LC method is carried out on a Luna C(18) column (150 x 4.6 mm) maintained at 40 degrees C. The mobile phase is composed of phosphate buffer (0.04 M, pH 3.0)-acetonitrile (84:16, v/v) run at a flow rate of 1.0 mL/min and detection at 272 nm. The chromatographic separation was obtained within 10 min, and it is linear in the concentration range of 0.05-5 microg/mL. Validation parameters, such as the specificity, linearity, precision, accuracy, and robustness, were evaluated, and results were within the acceptable range. Moreover, the proposed method was successfully applied for the assay of norfloxacin in the developed formulations.
建立并验证了一种稳定性指示反相液相色谱法,用于测定一种新的缓释片制剂中的诺氟沙星。液相色谱法在Luna C(18)柱(150×4.6 mm)上进行,柱温保持在40℃。流动相由磷酸盐缓冲液(0.04 M,pH 3.0)-乙腈(84:16,v/v)组成,流速为1.0 mL/min,检测波长为272 nm。10分钟内实现了色谱分离,在0.05-5 μg/mL的浓度范围内呈线性。对特异性、线性、精密度、准确度和稳健性等验证参数进行了评估,结果在可接受范围内。此外,该方法成功应用于所开发制剂中诺氟沙星的含量测定。