高效液相色谱法同时测定体内辛伐他汀和非诺贝特酸的含量  

Simultaneous determination of simvastatin and fenofibric acid in vivo by dual wavelength HPLC

作　　者：赵燕燕[1] 白洁[1] 苏芳[2] 韩媛媛[1] 王翠玲[2] 李月秋[1] 

机构地区：[1]河北大学医学实验中心,河北保定071000 [2]河北大学药学院,河北保定071002

出　　处：《中国医院药学杂志》2011年第12期998-1001,共4页Chinese Journal of Hospital Pharmacy

基　　金：河北省科技攻关项目(编号:05276101D-88);河北教育厅科学研究计划项目(编号:y2009315);河北省卫生厅医学科学研究重点课题计划项目(编号:0501520090570);河北省中医药管理局科研计划课题(编号:2008072)

摘　　要：目的：建立双波长高效液相色谱法同时测定体内辛伐他汀和非诺贝特酸浓度的方法。方法：移取血清，加入环己烷-二氯甲烷（3：1）混合溶液，沉淀蛋白后离心，上清液经氮气吹干，加流动相溶解后上机分析。采用Shimadzu VP-ODS分析柱（150mm×4．6mm），二极管阵列矩阵检测器，测定波长：辛伐他汀为238nm，非诺贝特酸为300nm，流动相：甲醇-水-10％磷酸（85：14：1），流速1．0mL·min^-1，柱温为25℃。结果：辛伐他汀、非诺贝特酸分别在0．20-25mg·L^-1（r=0．9999）和0．05～25mg·L^-1。（r=0．9999）范围内线性关系良好，最低检测分别为0．05mg·L^-1和0．01mg·L^-1。平均回收率分别为95．34％和91．80％，日内、日间精密度（RSD）均小于6．4％。结论：双波长高效液相色谱法同时测定体内辛伐他汀和非诺贝特酸浓度的定性定量方法简便快速、准确，适用于辛伐他汀和非诺贝特血药浓度的测定，以及合并用药后药动学、药效学和生物等效性方面的研究。OBJECTIVE To establish an HPLC method for the sinmhaneous determination of simvastatin and fenofibric acid in serum. METHODS The serum samples were centrifugalized after proteins precipitated with cyclohexane-dichlormethane （3： 1 ）. The supernatant was evaporated to dryness by N2 and the remains were dissolved by mobile phase. It was detected by a di- ode array detector. The chromatographic conditions included： a Shimadzu VP-ODS analytical column（150mm×4.6mm） at a temperature of 25 ℃, the mobile phase consisted of methanol water-10% phosphoric acid（85： 14： 1） at a flow rate of 1.0mL·min^-1. Simvastatin and fenofibric acid were determined by dual wavelength, simvastatin used 238 nm, fenofibric acid used 300 nm. RESULTS The linear ranges of simvastatin and fenofibric acid were 0. 20-25 mL·min^-1（r=0. 999 9） and 0. 05-25mL·min^-1（r =0. 999 9）, respeclively. The average recoveries of them were 95.34% and 91.80%, respectively, lntra-day RSD and inter-day RSD were less than 6. 4 %. CONCLUSION The method is simple, accurate and suitable for the determination of simvastmin and fenofibric acid in serum, it can be used for the study of the effects of drug combinations on pharmacokinetics, pharmacodynamics and bioequivalenee.

关 键 词：高效液相色谱法 双波长 辛伐他汀 非诺贝特酸 血药浓度 

分 类 号：R927.2[医药卫生—药学]