Wei Zhang, Bing-ren Xiang, Ying Zhan, Liyan Yu, Teng Wang, Cai-yun Wang
Center for Instrumental Analysis, China Pharmaceutical University (Key Laboratory of Drug Quality Control and Pharmacovigilance, Ministry of Education), Nanjing 210009, PR China.
J Chromatogr Sci. 2008 Nov-Dec;46(10):844-7. doi: 10.1093/chromsci/46.10.844.
A sensitive and selective high-performance liquid chromatographic-UV (HPLC-UV) method for the determination of bezafibrate in human plasma has been developed. Sample treatment was based on protein precipitation with a perchloric acid-methanol solution 10:90 (v/v). Analytical determination was carried out by HPLC with UV detection at 235 nm. Chromatographic separation was achieved on a C18 column by isocratic elution with acetonitrile-ammonium acetate aqueous solution (10 mmol/L; pH 4.0) (44:56, v/v) at a flow rate of 1.0 mL/min. The method was linear in the concentration range of 0.1-15.0 microg/mL. The lower limit of quantitation was 0.1 microg/mL. The intra-and inter-day relative standard deviation across three validation runs over the entire concentration range was less than 6.96%. The accuracy determined at three concentrations (0.2, 2.0, and 10.0 microg/mL for bezafibrate) was within +/- 10.0% in terms of accuracy. The method was successfully applied for the evaluation of pharmacokinetic profiles of bezafibrate dispersible tablet in 20 healthy volunteers. The results show that AUC, C(max), and T(1/2) between the testing formulation and reference formulation have no significant difference (P > 0.05). Relative bioavailability was 105.0 +/- 15.7%.
已开发出一种灵敏且具选择性的高效液相色谱 - 紫外检测法（HPLC - UV）用于测定人血浆中的苯扎贝特。样品处理基于用10:90（v/v）的高氯酸 - 甲醇溶液进行蛋白沉淀。分析测定通过在235 nm处进行紫外检测的HPLC来进行。在C18柱上，以乙腈 - 醋酸铵水溶液（10 mmol/L；pH 4.0）（44:56，v/v）以1.0 mL/min的流速进行等度洗脱实现色谱分离。该方法在0.1 - 15.0 μg/mL的浓度范围内呈线性。定量下限为0.1 μg/mL。在整个浓度范围内的三次验证运行中，日内和日间相对标准偏差均小于6.96%。在三个浓度（苯扎贝特为0.2、2.0和10.0 μg/mL）下测定的准确度在±10.0%以内。该方法成功应用于20名健康志愿者中苯扎贝特分散片的药代动力学特征评估。结果表明，受试制剂和参比制剂之间的AUC、C(max)和T(1/2)无显著差异（P > 0.05）。相对生物利用度为105.0 ± 15.7%。
