lc-msms法测定人血浆中卡络磺钠的浓度

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1、LC-MS/MS法测定人血浆中卡络磺钠的浓度赵华，宋敏，杭太俊(中国药科大学药学院药物分析教研室，南京210009)摘要目的：建立人血浆中卡络磺钠浓度的LC-MS/MS测定法，并用于卡络磺钠的人体药代动力学研究。方法：24名健康志愿者单剂量口服90mg卡络磺钠胶囊，于服药前及后0.17，0.33，0.5，0.67，1.0，1.25，1.5，2.0，3.0，4.0,5.0，6.0和8.0h分别采集血样，APCI正离子化LC-MS/MS法测定血浆中卡络磺钠的浓度。结果：卡络磺钠LC-MS/MS测定法在0.5ng∙mL-1～50ng∙mL-1范围呈现良好线性，方法回收率为92.0%～1

2、01.0%。批内、批间精密度RSD分别为1.18%～1.52%和5.51%～9.84%。主要血浆药动学参数Cmax为(20.92±8.35)ng∙mL-1，Tmax为(1.16±0.51)h，t1/2为(2.51±0.95)h，MRT为(4.11±1.09)h，AUC0-8为(65.87±25.31)h·ng∙mL-1，AUC0-¥为(75.53±28.63)h·ng∙mL-1，Vz/F为(5071.68±2713.88)L，CL/F为(1311.10±386.55)L∙h-1。结论：健康志愿者单剂量口服90mg卡络磺钠胶囊后，卡络磺钠血浆浓度-时间曲线符合二房室模型。Cmax在

3、9.77ng∙mL-1～38.88ng∙mL-1范围，Tmax在0.5h～3h范围，个体差异较大。关键词：卡络磺钠；药代动力学；LC-MS/MSDeterminationofcarbazochromesodiumsulfonateinhumanplasmabyLC-MS/MSZHAOHua*作者简介:赵华，女，药物分析硕士研究生Tel:(025)83271090E-mail:cucupig@hotmail.com,SongMin,HANGTai-jun(DepartmentofPharmaceuticalAnalysis,ChinaPharmaceuticalUniversity

4、,NanJing,210009，China)AbstractObjective:ToestablishanLC-MS/MSmethodforthedeterminationofcarbazochromesodiumsulfonateinhumanplasmaandstudyitspharmacokinetics.Methods:Asingleoraldoseof90mgcarbazochromesodiumsulfonatecapsuleswasgiventoeachof24Chinesehealthyvolunteers.Bloodsampleswerecollectedbef

5、oreand0.17，0.33，0.5，0.6716，1.0，1.25，1.5，2.0，3.0，4.0,5.0，6.0,8.0haftertheadministration.ThedrugplasmaconcentrationsweredeterminedbyavalidatedLC-MS/MSmethodinAPCIpositiveionmode.Results:ThecalibrationcurveoftheLC-MS/MSmethodwaslinearintherangeof0.5ng·mL-1-50ng·mL-1withtheaccuracyfrom90%to105%.T

6、heintra-dayandinter-dayprecession(RSD)were1.18%-1.52%and5.51%-9.84%,respectively.Themainpharmacokineticparametersofcarbazochromesodiumsulfonateafterasingleoraldose90mgwereasfollows,Cmax(20.92±8.35)ng∙mL-1，Tmax(1.16±0.51)h，t1/2(2.51±0.95)h，MRT(4.11±1.09)h，AUC0-8(65.87±25.31)h·ng∙mL-1，AUC0-¥(75

7、.53±28.63)h·ng∙mL-1，Vz/F(5071.68±2713.88)L，CL/F(1311.10±386.55)L∙h-1.Conclusion:Theplasmaconcentration-timeprofileofcarbazochromesodiumsulfonatefitstwocompartmentmodelsafteroraldoseof90mgcapsules.TherangesofCmaxandTmaxwere9.77ng∙mL-1-38.88ng∙