Bioequivalence and Pharmacokinetics Study of Losartan Potassium Tablets in Healthy Volunteers by LC-MS/MS Method

L Cheng-zhe;ZHNG Qun-ying;ZHOU Wen-ji;HUNG Ming;WNG Meng

Chinese Pharmaceutical Journal ›› 2011, Vol. 46 ›› Issue (14) : 1108-1111.

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PDF(781 KB)
Chinese Pharmaceutical Journal ›› 2011, Vol. 46 ›› Issue (14) : 1108-1111.

Bioequivalence and Pharmacokinetics Study of Losartan Potassium Tablets in Healthy Volunteers by LC-MS/MS Method

  • L Cheng-zhe1， ZHANG Quan-ying2， ZHOU Wen-jia2*， HUANG Ming2 ， WANG Meng2
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Abstract

OBJECTIVE To develope an LC-MS/MS method for the determination of losartan in human plasma， and to evaluate the pharmacokinetics and bioequivalence of losartan tablets in healthy volunteers. METHODS A single oral dose of reference and test tablets was given to 20 healthy male volunteers according to a randomized crossover design. Plasma concentrations were determined by LC-MS/MS after deproteinization by methanol. The pharmacokinetic parameters were calculated by DAS2.0. RESULTS The main pharmacokinetic parameters of losartan test and reference preparations were as follows： ρmax (222±131) and (226±166) μg·L-1， tmax (1.28±0.64) and (1.45±0.70) h， t1/2 (1.91±0.32) and (1.90±0.37) h， AUC0-12 h (450±191) and (446±227) μg·h·L-1， respectively. The relative bioavailability of the test preparation was (104.0 ±14.3)%. CONCLUSION The LC-MS/MS method is proved to be accurate， sensitive and convenient; the test tablets are bioequivalent to the reference tablets.

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losartan / pharmacokinetics / bioequivalence / LC-MS/MS

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L Cheng-zhe;ZHNG Qun-ying;ZHOU Wen-ji;HUNG Ming;WNG Meng . Bioequivalence and Pharmacokinetics Study of Losartan Potassium Tablets in Healthy Volunteers by LC-MS/MS Method[J]. Chinese Pharmaceutical Journal, 2011, 46(14): 1108-1111

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