Matar K M, Nicholls P J, Bawazir S A, al-Hassan M I, Tekle A
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
J Pharm Biomed Anal. 1998 Jul;17(3):525-31. doi: 10.1016/s0731-7085(97)00234-3.
A rapid sensitive and simple high-performance liquid chromatographic (HPLC) method for the determination of lamotrigine in plasma is described. The drug was extracted from 100 microliters of plasma with chloroform:isopropanol (95:5% v/v) in the presence of 100 microliters of phosphate buffer (10 mM). The extract was evaporated and the residue was reconstituted with mobile phase and injected onto the HPLC system. The drug and the internal standard (chloramphenicol) were eluted from a Symmetry C18 stainless steel column at ambient temperature with a mobile phase consisting of 0.01 M potassium-acetonitrile-methanol (70.20:10% v/v/v), adjusted to pH 6.7, at a flow rate of 1.3 ml min-1 and the detector was monitored at 214 nm. Quantitation was achieved by measurement of the peak-area ratio of the drug to the internal standard and the lower limit of detection for lamotrigine in plasma was 20 ng ml-1. The intraday precision ranged from 3.34 to 6.12% coefficient of variation (CV) and the interday precision ranged from 2.15 to 8.34% CV. The absolute and relative recoveries of lamotrigine ranged from 86.93 to 90.71% and from 95.18 to 107.13%, respectively. The method was applied in studying the pharmacokinetics of lamotrigine administered orally to rabbits. This reliable micro-method would have application in pharmacokinetic studies of lamotrigine where only small sample sizes are available, e.g. paediatric patients.
本文描述了一种快速、灵敏且简便的高效液相色谱(HPLC)法,用于测定血浆中的拉莫三嗪。在100微升磷酸盐缓冲液(10 mM)存在的情况下,用氯仿:异丙醇(95:5% v/v)从100微升血浆中提取该药物。提取物经蒸发后,残渣用流动相复溶并注入HPLC系统。药物和内标(氯霉素)在室温下从Symmetry C18不锈钢柱上洗脱,流动相由0.01 M醋酸钾 - 乙腈 - 甲醇(70:20:10% v/v/v)组成,pH调至6.7,流速为1.3 ml min-1,检测器在214 nm处进行监测。通过测量药物与内标的峰面积比进行定量,血浆中拉莫三嗪的检测下限为20 ng ml-1。日内精密度的变异系数(CV)范围为3.34%至6.12%,日间精密度的CV范围为2.15%至8.34%。拉莫三嗪的绝对回收率和相对回收率分别为86.93%至90.71%和95.18%至107.13%。该方法应用于研究口服给予兔子的拉莫三嗪的药代动力学。这种可靠的微量方法可应用于仅有少量样本可用的拉莫三嗪药代动力学研究,例如儿科患者。