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呱仑酸钠血药浓度HPLC测定方法研究

Study on the Plasma Level Determination of Sodium Gualenate by HPLC

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【作者】 沈怡; 张丹; 曾经泽; 邓勇;

【Author】 SHEN Yi 1,ZHANG Dan 2,ZENG Jing-ze 2 and DENG Yong 2 (1.Center of Technique,Chengdu Kanghong Pharmaceutical Co.Ltd.; 2.School of Pharmacy,West China University of Medical Sciences,Chengdu\ 610041)

【机构】 成都康弘制药有限公司技术中心; 华西医科大学药学院!成都610041;

【摘要】 目的 :建立水溶性药物呱仑酸钠血药浓度的高效液相色谱分析方法。方法 :以对二甲氨基苯甲醛为内标 ,在比较了固相萃取、离子对萃取及沉淀蛋白 -脱水法等 3种预处理方法的基础上 ,采用沉淀蛋白 -脱水法预处理兔血浆样品 ,分析柱为 μBondapakC18柱 (2 5 0mm× 4 6mm ,10 μm) ,流动相为 pH 7 0的 0 0 1mol·L-1磷酸盐缓冲液 -甲醇 (5 0∶5 0 ) ,流速1mL·min-1,在 2 93nm波长处检测 ,按内标法定量。结果 :血药浓度线性范围为 0 1~ 10 0mg·L-1(r=0 9997) ,最低检测浓度为 0 0 2mg·L-1(S/N >3) ,萃取回收率在 79 5 %~ 86 4% (n =5 ) ,分析方法回收率在 93 1%~ 95 5 % (n =5 ) ,日内和日间RSD分别为 1 2 %~ 1 8%和 1 9%~ 3 1% (n =5 )。结论 :本法简便、准确、精密度高、重现性好 ,适用于呱仑酸钠的体内研究

【Abstract】 Objective:To establish HPLC method for determination of water-soluble drug sodium gualenate(SGL)in rabbit plasma. Methods:In the experiments,three clean-up techniques of rabbit plasma samples(ion-pair extraction,solid-phase extraction and protein precipitation-dehydration method) were investigated and compared comprehensively,and protein precipitation-dehydration was chosen to pretreat plasma samples before HPLC analysis.Using p -(dimethylamino)-benzaldehyde as an internal standard(IS),the SGL and IS were separated on the μBondapak C 18 column(250 mm×4 6 mm,10 μm)with 0 01 mol·L -1 phosphate buffer of pH 7 0-methanol(50∶50) as the mobile phase,a flow rate of 1 mL·min -1 and detected at 293 nm.Results:The linear range of calibration curve was within drug plasma concentrations of 0 1~10 0 mg·L -1 ( r =0 999 7),the detection limit was 0 02 mg·L -1 ( S/N >3),the extraction recovery was 79 5%~86 4%( n =5),the analytical recovery was 93 1%~95 5%( n =5),the within-day RSD and between-day RSD were 1 2%~1 8% and 1 9%~3 1%( n =5)respectively.Conclusions:The method possesses merits of simplicity,sensitivity,good accuracy,high precision,and fine reproducibility,which was suitable for the study of SGL in vivo.

  • 【文献出处】 药物分析杂志 ,Chinese Journal of Pharmaceutical Analysis , 编辑部邮箱 ,2001年05期
  • 【分类号】R969
  • 【被引频次】3
  • 【下载频次】140
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