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1、药学学报ActaPharmaceuticaSinica2009,44(7):771−777·771·EstablishmentofHPLC-ESI-MSmethodforthedeterminationofeplerenoneinhumanplasmaanditspharmacokinetics11*2*1112QIANWen-juan,DINGLi,WENAi-dong,GONGBin,LENGYe,YUNChang-hong,YANGLin(1.DepartmentofPharmaceuticalAnalysis,ChinaPharmaceuti
2、calUniversity,Nanjing210009,China;2.OrganizationforStateDrugClinicalTrial,XijingHospitalAffiliatedtotheFourthMilitaryMedicalUniversity,Xi’an710032,China)Abstract:Asensitivehighperformanceliquidchromatography-electrosprayionization-massspectrometry(HPLC-ESI-MS)methodwasestablish
3、edforthedeterminationofeplerenone(EP)inhumanplasma.TheplasmasamplesofEPwereextractedwithethylacetateandseparatedbyHPLConareversedphaseC18column−1withamobilephaseof10mmol·Lammoniumacetatewatersolution-methanol(30∶70,v/v).EPwasdeterminedwithelectrosprayionization-massspectrometry
4、(ESI-MS)intheselectedionmonitoring(SIM)mode.The−1calibrationcurveswerelinearovertherangeof2−4000ng·mLforEP.Thelowerlimitofquantificationwas−12ng·mL.ThemethodhasbeensuccessfullyappliedinthepharmacokineticstudyoftheEPtablets.ThemainpharmacokineticparametersofEPafteroraladministra
5、tionof25mg,50mg,100mgwereasfollows,t1/2:−1(4.9±2.1),(4.7±1.5),(5.9±1.2)h;AUC0−∞:(4402±1735),(8150±2509),(13783±4102)µg·h·L;andMRT:(6.2±2.1),(6.6±1.3),and(7.2±1.6)h.ParametersofEPafteroraladministrationofmultipledosesof−150mgwereasfollows,t1/2:(6.1±1.7)h;AUCss:(10071±4220)µg·h·L
6、;MRT:(8.1±2.3)h;andDF:(3.2±1.0).Keywords:eplerenone;HPLC-ESI-MS;pharmacokineticsCLCnumber:R917Documentcode:AArticleID:0513-4870(2009)07-0771-07HPLC-ESI-MS法测定人血浆中依普利酮的浓度及其药代动力学研究11*2*1112钱文娟,丁黎,文爱东,龚斌,冷晔,云昌宏,杨林(1.中国药科大学药物分析教研室,江苏南京210009;2.中国人民解放军第四军医大学西京医院国家药品临床试验机构,陕西西安710032)
7、摘要:建立测定人血浆中依普利酮浓度的HPLC-ESI-MS法。依普利酮血浆样品采用乙酸乙酯提取,色谱柱−1为反相色谱C18柱,流动相为10mmol·L醋酸铵水溶液-甲醇(30∶70,v/v)。质谱离子源为电喷雾离子化(ESI)−1−1源,选择性离子检测方式检测;血浆样品在2～4000ng·mL内线性良好,定量下限为2ng·mL。本文采用该方法对健康受试者的人体药代动力学进行研究,3个单剂量(25mg、50mg和100mg)口服给药后的药代动力学参数分别为t1/2:(4.9±2.1)、(4.7±1.5)、(5.9±1.2)h;AUC0−∞:(4402±
8、1735)、(8150±2509)、(13783±4102)−1µg·h·L;MRT:(6.2±2.1)、(
