摘要
目的:建立测定人血浆中氯雷他定的反相高效液相色谱法。方法:血浆样品碱化后用乙醚萃取。色谱柱为C_(18)柱(150mm×4.6mm,5μm),流动相为50mmol·L^(-1)磷酸盐缓冲液(磷酸调pH4.0)-乙腈(62:38),流速为1.50mL·min^(-1),荧光检测波长:Ex290nm,Em460nm。外标法峰面积定量。结果:测定方法在1.0～100.0μg·L^(-1)范围内具良好的线性关系,萃取回收率为86.0％～99.7％,方法回收率为85.0％～100.4％,日内、日间RSD小于15％,最低定量浓度为1.00μg·L^(-1)。结论:本测定方法具灵敏、准确、快速的优点,适用于氯雷他定片剂的药代动力学和生物利用度等的研究。
Objective: To develop a simple, sensitive and rapid RP - HPLC with fluorescence detector method for the determination of loratadine in human plasma. Methods: The plasma samples were extracted with ether. The solvent was evaporated to dryness at 40℃in a water bath. The analysis involved a 150 mm × 4. 6 mm column packed with C18 (5μm ). The mobile phase consisted of 50 mmol · L-1 ammoninium dihydrogen phosphate solu-tion ( adjust pH to 4. 0 with H3PO4 ) - acetonitrile ( 62: 38 ) with a flow rate of 1. 50 mL · min-1. The fluorescence detector were set at Ex 290 nm and Em 460 nm. Results: A good linearity was obtained in the range of 1. 0 -100. 0 μg · L-1 ( r = 0. 999 7 ) . The extraction recovery was between 86. 0% - 99. 7% . The method recovery was more than 85% . The relative Standard deviations of within - day and between - day were less than 15% (n = 6). The minimal detectable concentration in plasma was 1. 00 μg · L-1. Conclusion : The established method was shown to be sensitive, accurate and simple for the determination of loratadine Ievels in human plasma. It was suitable for the pharmacokinetics and bioavailability study of loratadine.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2002年第4期296-298,共3页
Chinese Journal of Pharmaceutical Analysis
