Ulu Sevgi Tatar, Aydoğmuş Zeynep
Istanbul University, Faculty of Pharmacy, Department of Analytical Chemistry, 34416, Istanbul, Turkey.
J Chromatogr Sci. 2012 Aug;50(7):615-9. doi: 10.1093/chromsci/bms056. Epub 2012 May 2.
A new high-performance liquid chromatographic method is described for the determination of bisoprolol in human plasma. The proposed method was based on the derivatization of bisoprolol with 4-chloro-7-nitro-2,1,3-benzoxadiazole in borate buffer at pH 9.5 to yield a fluorescent product. Chromatographic separation of bisoprolol was achieved by using isocratic elution at a flow rate of 1.2 mL/min on a C18 reversed-phase column (Inertsil, 4 μm, 150 4.6 mm) at 40°C. The mobile phase used for the analysis was methanol-water (70:30, % v/v). Fluorescence detector was used at the excitation and emission wavelengths of 458 and 525 nm, respectively. The method was validated for linearity, limit of detection, limit of quantification, precision, accuracy, recovery and system suitability. The assay was linear over the concentration range of 10-2000 ng/mL. This method was applied in pharmacokinetic studies of bisoprolol preparations in healthy volunteers.
描述了一种用于测定人血浆中比索洛尔的新型高效液相色谱法。该方法基于比索洛尔在pH 9.5的硼酸盐缓冲液中与4-氯-7-硝基-2,1,3-苯并恶二唑衍生化以产生荧光产物。比索洛尔的色谱分离是通过在40°C下使用C18反相柱（Inertsil，4μm，150×4.6mm）以1.2 mL/min的流速进行等度洗脱实现的。用于分析的流动相为甲醇-水（70:30，% v/v）。荧光检测器分别在激发波长458nm和发射波长525nm下使用。该方法在线性、检测限、定量限、精密度、准确度、回收率和系统适用性方面进行了验证。该测定法在10 - 2000 ng/mL的浓度范围内呈线性。该方法应用于健康志愿者中比索洛尔制剂的药代动力学研究。
