de Melo Janine, Hurtado Felipe Kellermann, Poitevin Fabia Silveira, Flores Fernanda Cramer, Zimmermann Estevan Sonego, Dalmora Sergio Luiz, Rolim Clarice Madalena Bueno
Programa de Pós-Graduação em Ciências Farmacêuticas, Centro de Ciências da Saúde, Universidade Federal de Santa Maria, 97105-900, Santa Maria, RS, Brazil.
J Chromatogr Sci. 2010 May-Jun;48(5):362-6. doi: 10.1093/chromsci/48.5.362.
An isocratic high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of bezafibrate in biological fluids. Bezafibrate was separated on a C(18) analytical column (150 x 4.6 mm i.d., 5 microm particle size) with 0.01 M phosphate buffer (pH 3.5)-acetonitrile-methanol (50:40:10) as mobile phase at a flow rate of 1.0 mL/min. The UV detector was set to 230 nm. Bezafibrate was extracted from human plasma using a simple liquid-liquid extraction with tert-butyl methyl ether. Parameters such as linearity, precision, accuracy, recovery, specificity, and stability were evaluated by method validation studies. All the parameters remained within acceptable limits. The validated procedure was linear in the concentration range of 0.2-50 microg/mL. The proposed method used for individual drug determinations is applicable for therapeutic monitoring purposes as well as for use in pharmacokinetic investigations. As an example, the practical quantification limit for bezafibrate in plasma was about 0.05 microg/mL with precision of 10.2% and accuracy of 112.6%. The method was applied in a study of the pharmacokinetics of bezafibrate in six healthy volunteers, who ingested a single oral dose of 200 mg.
建立了一种等度高效液相色谱（HPLC）法并进行了验证，用于测定生物流体中的苯扎贝特。苯扎贝特在C(18)分析柱（内径150×4.6 mm，粒径5μm）上分离，以0.01 M磷酸盐缓冲液（pH 3.5）-乙腈-甲醇（50:40:10）为流动相，流速为1.0 mL/min。紫外检测器设置为230 nm。使用叔丁基甲基醚通过简单的液-液萃取从人血浆中提取苯扎贝特。通过方法验证研究评估了线性、精密度、准确度、回收率、特异性和稳定性等参数。所有参数均保持在可接受范围内。验证后的方法在0.2 - 50μg/mL的浓度范围内呈线性。所提出的用于个体药物测定的方法适用于治疗监测目的以及药代动力学研究。例如，血浆中苯扎贝特的实际定量限约为0.05μg/mL，精密度为10.2%，准确度为112.6%。该方法应用于一项对6名健康志愿者进行的苯扎贝特药代动力学研究，这些志愿者单次口服200 mg剂量。
