See Khoo Lay, Elbashir Abdalla A, Saad Bahruddin, Ali Abdussalam Salhin Mohamed, Aboul-Enein Hassan Y
School of Chemical Sciences, Universiti Sains Malaysia, Penang, Malaysia.
Biomed Chromatogr. 2009 Dec;23(12):1283-90. doi: 10.1002/bmc.1251.
A simple, rapid and validated capillary electrophoretic method has been developed for the separation and determination of ofloxacin and ornidazole in pharmaceutical formulations with detection at 230 nm. Optimal conditions for the quantitative separations were investigated. Analysis times shorter than 4 min were obtained using a background electrolyte solution consisting of 25 mmol/L phosphoric acid adjusted with 1 M Tris buffer to pH 8.5, with hydrodynamic injection of 5 s and 20 kV separation voltage. The validation criteria for accuracy, precision, linearity and limits of detection and quantitation were examined and discussed. An excellent linearity was obtained in concentration range 25-250 microg/mL. The detection limits for ofloxacin and ornidazole were 1.03 +/- 0.11 and 1.80 +/- 0.06 microg/mL, respectively. The proposed method has been applied for the analysis of ofloxacin and ornidazole both individually and in a combined dosage tablet formulation. The proposed validated method showed recoveries between 96.16 and 105.23% of the nominal contents.
已开发出一种简单、快速且经过验证的毛细管电泳方法，用于分离和测定药物制剂中的氧氟沙星和奥硝唑，检测波长为230 nm。研究了定量分离的最佳条件。使用由25 mmol/L磷酸并用1 M Tris缓冲液调节至pH 8.5的背景电解质溶液，通过5 s的流体动力学进样和20 kV的分离电压，获得了短于4分钟的分析时间。检查并讨论了准确性、精密度、线性以及检测限和定量限的验证标准。在25 - 250 μg/mL的浓度范围内获得了良好的线性。氧氟沙星和奥硝唑的检测限分别为1.03±0.11和1.80±0.06 μg/mL。所提出的方法已应用于单独以及复方片剂制剂中氧氟沙星和奥硝唑的分析。所提出的经过验证的方法显示回收率在标称含量的96.16%至105.23%之间。
