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《Chinese Journal of Clinical Pharmacy》 2013-01
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Determination of losartan and its metabolite in human plasma by LC-MS/MS and bioequi valence study of losartan potassium tablets

Yuan Fei;Xu Jianan;Wang Hong;Chu Nannan;Xu Hongrong;Li Xuening;Chen Weili;Department of Clinical Pharmacology,Zhongshan Hospital,Fudan University;  
AM To build a LC-MS/MS method to evaluate bioavailability and bioequivalence of losaitan and its metabolite after oral administration of test preparation and reference preparation of losaitan potassium in healthy volunteers.METHODS This was an open,randomized,single dose and 2×2 cross-over trial.A total of 24 Chinese healthy male subjects were given oral dose of SO mg test or reference preparation losaitan.Blood samples were collected up to 24 h after dosing.Plasma concentrations of losaitan and losaitan acid were determined by LC-MS/MS.RESULTS The t_(max) of losaitan in test preparation and reference preparation were(1.42 ± 0.99) and(1.50 ± 1.14)h.p_(max) were(273.44 ± 170.44) and(285.96± 157.89)μg·L-1,AUC_(o→t)were(618.51 ±386.50) and(587.92±331.92)μg·h·L~(-1).Relative bioavailability was(105.87 ± 26.07)%.The t_(max) of losaitan acid in test preparation and reference preparation were(3.69±1.16) and(3.96 ± 1.30)h,p_(max) were(444.53 ± 133.53) and(412.88 ± 128.80)μg·L~(-1),AUC_(o→t) were(3 563.52±932.14) and(3 398.77±915.06)μg·h·L~(-1).Relative bioavailability of losartan acid was(105.92± 14.65)%.CONCLUSION The LC-MS/MS method is proved to be a sensitive and suitable for pharmacokinetic research and determination of losaitan.The two preparations are bioequivalent.
【CateGory Index】: R96
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【Citations】
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