Determination the concentration of losartan and hydrochlorothiazide in healthy volunteers and study on its relative bioavailability by LC-MS/MS
10.3969/j.issn.1001-6821.2009.04.013
- VernacularTitle:液相色谱串联质谱法测定人血浆中氯沙坦/氢氯噻嗪的浓度及其人体相对生物利用度研究
- Author:
Qian LIU
1
;
Lu WANG
;
Hong-Wei SHANG
;
Hui ZHAO
;
Lun YANG
Author Information
1. 沈阳药科大学
- Keywords:
losartan/hydrochlorothiazide;
bioavailability;
HPLC-MS/MS
- From:
The Chinese Journal of Clinical Pharmacology
2009;25(4):341-345
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish sensitive and selective method and study on its relative bioavailability in healthy volunteers by LC - MS/ MS. Method A single oral dose of two different dosage losartan/hydrochlorothiazide (50 mg/12.5 mg) tablets was administrated to 20 healthy volunteers in a randomized cross - over design. Plasma concen-tration of losartan and hydrochlorothiazide were determined by HPLC -MS/MS method, and relative bioavailability was evaluated by DAS 1.0.Results Main pharmacokinetic parameters for losartan were as follows: tmaxwere (1.09±0.56) hand (1.12±0.55)h, Cmax were (118.9±68.9) and (110.2±51.0)ng- mL-1, t1/2were(3.15±0.76) and(2.96±0.71)h, AUC0-twere (226.2±65.0) and (241.9±77.4)ng· h · mL-1, AUC0-∞were (250.5±68.7 ) and (265.7±81.5 )ng · h · mL-1 for the test and reference drugs. Main pharmacokinetic parameters for hydrochlorothiazide were as follows: tmax were (1.93 ±0.54) hand (2.25±0.60) h, Cmaxwere (73.2±11.0) and (74.5±17.4) ng·mL-1, t1/2were (9.45±3.57) and (8.33±2.58) h, AUC0-t, were (401.8±138.3)and (390.6±149.3) ng · h · mL-1, AUC0-∞ were (438.2±146.8) and (415.5 ± 156.1) ng · h · mL-1 for the test and refer-enee drugs. The relative bioavailabilities were (96.5 ± 21.2 ) % and ( 106.8 ± 22.9 ) % for losartan and hydrochloroth-iazide, respectively. Conclusion The test and reference drugs of losartan/hydroehlorothiazide are bioequivalent.
