Cetin Sevil Müge, Atmaca Sedef
Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Beyazit, 34116 Istanbul, Turkey.
J Chromatogr A. 2004 Mar 26;1031(1-2):237-42. doi: 10.1016/j.chroma.2003.11.020.
A simple and reliable high-performance liquid chromatographic (HPLC) method with UV-Vis detection has been developed and validated for the determination of vigabatrin (VG) in human plasma and urine. The samples were pre-column derivatizated with 1,2-naphthoquinone-4-sulphonic acid sodium salt (NQS). A good chromatographic separation was achieved on a C18 column with a mobile phase consisting of acetonitrile and 10 mM orthophosphoric acid (pH 2.5) gradient elution. Tranexamic acid was used as an internal standard (I.S.). The method was linear over the concentration range of 0.8-30.0 microg/ml for both samples. The method is precise (relative standard deviation (R.S.D.) <9.13%) and accurate (relative mean error (RME) <-8.75%); analytical recoveries were 81.07% for plasma and 83.05% for urine. The assay was applied to pharmacokinetic study in a healthy volunteer after a single oral administration of 1 g of vigabatrin.
已开发并验证了一种采用紫外可见检测的简单可靠的高效液相色谱（HPLC）方法，用于测定人血浆和尿液中的氨己烯酸（VG）。样品用1,2-萘醌-4-磺酸钠盐（NQS）进行柱前衍生化。在C18柱上以乙腈和10 mM正磷酸（pH 2.5）梯度洗脱组成的流动相实现了良好的色谱分离。氨甲环酸用作内标（I.S.）。该方法在两个样品的0.8 - 30.0 μg/ml浓度范围内呈线性。该方法精密度良好（相对标准偏差（R.S.D.）<9.13%）且准确度高（相对平均误差（RME）<-8.75%）；血浆的分析回收率为81.07%，尿液的分析回收率为83.05%。该测定法应用于一名健康志愿者单次口服1 g氨己烯酸后的药代动力学研究。
