Determination of anaprazole in human plasma by LC-MS/MS in pharmacokinetic study
10.16438/j.0513-4870.2016-0508
- VernacularTitle:LC-MS/MS法测定人血浆中的安纳拉唑及药动学初步应用
- Author:
Dong-xia CHENG
1
;
Xiao-jian DAI
2
;
Yi-fan ZHANG
2
;
Yong-qian WU
3
;
Chong-tie SHI
3
;
Xi-feng MA
3
;
Jin LI
3
;
Xiao-yan CHEN
2
;
Da-fang ZHONG
1
Author Information
1. College of Pharmacy, Zhejiang University of Technology, Hangzhou 310014, China
2. Shanghai Institute of Materia Medica, Shanghai 201203, China
3. Xuan Zhu Pharma Co., Ltd., Jinan 250100, China
- Publication Type:ORIGINAL ARTICLES
- Keywords:
LC-MS/MS;
anaprazole;
proton pump inhibitor;
clinical pharmacokinetics
- From:
Acta Pharmaceutica Sinica
2016;51(12):1885-
- CountryChina
- Language:Chinese
-
Abstract:
Anaprazole is a proton pump inhibitor clinically used for curing peptic ulcer. A rapid, sensitive and convenient LC-MS/MS method was first established for the determination of anaprazole in human plasma. d3, 13C-anaprazole was used as internal standard (IS). After extraction from human plasma by protein precipitation with acetonitrile, all components were separated on an Extend C18 column (100 mm×4.6 mm, 3.5 μm). The assay was linear over the concentration range of 5.00-3 000 ng·mL-1 (r2 > 0.995). The method was successfully applied to a pharmacokinetic study of 40 mg anaprazole enteric-coated tablets in 14 Chinese healthy volunteers under fasting or high fat diet conditions. Cmax was (1 020±435) ng·mL-1 and AUC0-t was (2 370±754) h·ng·mL-1 under fasting condition. And Cmax was (538±395) ng·mL-1 and AUC0-t was (1 610±650) h·ng·mL-1 under high fat diet condition. The plasma results suggest that the exposure of anaprazole is reduced by the high fat diet.
