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作 者:何海霞[1] 周远大[1] 杨辉[1] 陈锋杰[2] 李岑[2] 郑永[3]
机构地区:[1]重庆医科大学附属第一医院临床药理研究室,重庆400016 [2]重庆医科大学附属第一医院药剂科,重庆400016 [3]重庆医科大学附属第二医院药剂科,重庆400010
出 处:《中国新药与临床杂志》2004年第12期862-864,共3页Chinese Journal of New Drugs and Clinical Remedies
摘 要:目的 :建立高效液相色谱法 (HPLC)测定西洛他唑在健康人体内的药动学参数。方法 :血浆样品以地西泮作内标 ,经乙醚提取并浓缩进样 ;采用HYPERSILC18分析柱 (2 0 0mm× 5 .0mm ,5 μm) ,以乙腈 磷酸盐缓冲液 (5 0∶5 0 )为流动相 ,流速 1.0mL·min- 1;柱温 2 5℃ ;在紫外 2 5 7nm处检测。结果 :标准曲线线性范围为 0 .0 2 73~ 3.4 880mg·L- 1,r=0 .9994 ;方法回收率 91.74 %~ 110 .0 9% ;日内RSD为 1.0 2 %~ 7.4 2 % ,日间RSD为 5 .0 8%~6 .85 %。结论 :HPLC测定西洛他唑血药浓度灵敏、可靠 ,回收率高 ,结果准确 。AIM: To establish a high performance liquid chromatography (HPLC) method to determine the pharmacokinetic of cilostazol in healthy volunteers. METHODS: The drug and internal standard (diazepam) were extracted from plasma with ether. The compounds were separated on a HYPERSIL C_(18) column (200 mm×5.0 mm, 5 μm ). The mobile phase was composed of acetonitrile∶0.01 moL·L^(-1) KH_2PO_4(50∶50), the flow rate was 1.0 mL·min^(-1). The column temperature was 25 ℃. The detection wavelength was UV 257 nm. RESULTS: A good linearity was obtained from 0.0273 to 3.4880 mg·L^(-1) in plasma with a correlation coefficient of 0.9994. The recovery of method were from 91.74 to 110.09 %. The intra-day and inter-day RSD were (1.02~7.42) % and (5.08~(6.85) %,) respectively. CONCLUSION: The HPLC method is sensitive, a good recovery, accurate and reproducible and can be used for clinical pharmacokinetic and bioequialent study of cilostazol.
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