高效液相色谱法测定苯妥英钠血药浓度.docVIP

高效液相色谱法测定苯妥英钠血药浓度[摘要] 目的：建立测定血清中苯妥英钠浓度的高效液相色谱法。方法：以Hypersil C18柱（4.6 mm×200 mm，10 μm）为色谱柱，流动相为甲醇-水（50∶50），流速为0.8 ml/min，检测波长为230 nm，血清样品加入3 μl硫酸溶液（6 M）混匀后用重蒸乙醚提取。结果：苯妥英钠血清样品线性范围为2.00～150.00 mg/L，低、中、高三种不同浓度（8.33、33.33、100.00 mg/L）加样回收率分别为98.40%、95.50%、102.71%，日内、日间RSD均小于5%。结论：本方法准确性好，灵敏度高，操作简便，可满足苯妥英钠血药浓度监测要求 [关键词] 苯妥英钠；血药浓度；高效液相色谱法 [中图分类号] R969.4 [文献标识码] A [文章编号] 1673-7210（2011）12（a）-072-02 Determination on the concentration of Phenytoin Sodium in serum by HPLC ZUO Jing, SONG Xinwen, WANG Yang, XU Qiong, LIU Xin Department of Pharmaceutical, the Children′s Hospital in Wuhan City, Hubei Province, Wuhan 430016, China [Abstract] Objective: To establish HPLC method to determine the concentration of Phenytoin Sodium in serum. Methods: The chromatographic column was Hypersil C18 (4.6 mm×200 mm, 10 μm), the mobile phase was methanol and water (50∶50), the flow rate was 0.8 ml/min, and the detective wavelength was 230 nm. 3 μl sulphuric acid solution (6 M) was added to serum and was mixed evenly, then Phenytoin Sodium was extracted by evaporated ethylether. Results: The linear range of Phenytoin Sodium in serum was 2.00-150.00 mg/L. The recovery rates of mild, middle and high concentration (8.33, 33.33, 100.00 mg/L) were 98.40%, 95.50%, 102.71% respectively, and the within-day RSD and day to day RSD were both lower than 5%. Conclusion: The method is accurate, sensitive and simple, which can satisfy the requisition of determination of Phenytoin Sodium in serum. [Key words] Phenytoin Sodium; Serum concentration; HPLC 苯妥英钠是临床上应用最广泛的抗癫痫药物之一，其抗癫痫效应显著而镇静作用轻微。但本药属于饱和代谢动力学药物，用量的轻微增加就可引起血药浓度的显著上升，临床应用不易掌握剂量，必须进行血药浓度监测[1]。高效液相色谱法测定苯妥英钠血药浓度已有报道[2-4]，但大多提取过程繁锁费时，色谱条件不太令人满意。为此本文建立了一种简便、快速、准确的高效液相色谱法测定苯妥英钠血药浓度，现报道如下： 1 仪器与试药 1.1 仪器 Agilent1100高效液相色谱仪，包括G1311A-四元泵、G13222－脱气机、G1313A-柱温箱；G1314A-UV紫外检测器、HP化学工作站（美国HP公司）；WH-1微型旋涡混合仪（上海沪西分析仪器厂）；LDZ4-0.8A台式离心机（北京医用离心机厂）；AB204万分之一电子分析天平（瑞士产）；旋转蒸发器（上海亚荣生化仪器厂） 1.2 试药 苯妥英钠对照品（中国药品生物制品检定所，批号：100210-200401）；乙醚为分析纯