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目的建立测定人血浆中替米沙坦的液质联用方法.方法采用乙腈直接沉淀血浆蛋白后由ODS柱分离,质谱检测器测定.结果该方法的线性范围为2～500μg·L-1(r=0.999 2),方法回收率在95.8%～105.2%之间,日内和日间精密度都＜10%.采用自身对照交叉试验,单剂量分别给予20名男性健康志愿者2种国产替米沙坦片40 mg,其主要药动学参数ρmax为(220.70±95.80)和(233.11±105.52)μg·L-1,AUC0→96为(1 908.54±650.43)和(1 986.26±553.24)μg·h·L-1,t1/2为(24.1±4.2)和(24.8±3.8)h;tmax为(1.8±0.6)和(1.7±0.7)h.结论两种制剂间的主要动力学参数无明显差异,为生物等效制剂,其相对生物利用度为(95.6±6.4)%.“,”AIM To establish a new HPLC mass spectrometry method to determine telmisartan in human plasma.METHODS The method involved deproteinating samples with acetonitrile. The samples were separated by ODS column and determined by mass detector. RESULTS The calibration curve of telmisartan was linear within the range of 2 - 500tions of within day and between day were less than 10%. To study the pharmacokinetic and relative bioavailability of telmisartan tablets , two formulations of telmisartan tablets were given to 20 healthy male volunteers according to a randomized two-way cross-over design. The pharmacokinetic parameters of the two formulations were(220.70 ± 95.80) and (24.1±4.2) and (24.8±3.8)h for t1/2; (1.8±0.6) and (1.7±0.7)h for tmax respectively. CONCLUSION The statistic analyses showed that there are no significant differences between the ρmax, AUC0→96, ti/2 and tmax values of the two formulations. The relative bioavailability of tablets I with respect to tablets Ⅱ are (95.6 ± 6.4) %. Bioequivalance is observed between the two tablets.