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《Journal of China Pharmaceutical University》 2004-06
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Determination of Telmisartan in Human Plasma by HPLC-MS and Study of Its Pharmacokinetics

WU Jie,FENG Fang,JIANG Juan-Juan,TIAN Yong (Department of Pharmaceutical Analysis,China Pharmaceutical University,Nanjing 210009,China)  
AIM:To established an HPLC-MS method for the study of pharmacokinetics and bioequivalence of telmisartan in human body.METHOD:Diazepam was used as internal standard.After adding diazepam,the plasma samples were extracted with ethyl acetate and determined by HPLC-MS.The analysis was carried out on a Shimadzu VP-ODS column(150 mm×4.6 mm ID,packed with 5 μm C 18 Silica RP particle)at 30 ℃.The mobile phase consisted of methanol-0.01 mol/L ammonium acetate(70∶30,v/v) with the flow rate of 1.0 ml/min.HPLC-MS was performed in the selected ion monitoring(SIM)mode using target ions at m/z 515.6 for telmisartan and m/z 285.5 for diazepam.A randomized cross over design was performed on 20 healthy volunteers.In the two study periods,a single 40 mg dose of each capsule was administered to each volunteer.RESULT:The linear calibration curve was obtained in the range of 0.5~400 ng/ml(r=0.9998).The detection limit of telmisartan in plasma was 0.1 ng/ml.The average recovery was more than 80%.c max of telmisartan in plasma for the test and reference formulations are(173.9±30.4)and(178.2±35.5)ng/ml at (1.4±0.4) and (1.6±0.6) h,respectively.t 1/2 is (19.7±3.0) and (20.2±3.6) h respectively.The relative bioavailability of the test formulation was(101.2±13.0)%.CONCLUSION:The two formulations are bioequivalent.
【CateGory Index】: R969.1
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