223 0

Quantification of Imidapril in Human Plasma Using the LC-MS/MS Method for Bioequivalence and Pharmacokinetic Studies

Title
Quantification of Imidapril in Human Plasma Using the LC-MS/MS Method for Bioequivalence and Pharmacokinetic Studies
Author
강주섭
Keywords
Angiotensin-converting enzyme (ACE) inhibitor; bioequivalence; imidapril; korean volunteers; LC-MS/MS; Pharmacokinetics
Issue Date
2016-01
Publisher
BENTHAM SCIENCE PUBL LTD
Citation
CURRENT PHARMACEUTICAL ANALYSIS, v. 12, NO 2, Page. 107-113
Abstract
We developed the LC-MS/MS method through a comparison of the pharmacokinetic characteristics of imidapril to assess the bioequivalence of two types of imidapril in 31 normal Korean subjects. Blood samples were collected at 13 time points for 12 h after dosing and detected by LC-MS/MS in the range of 0.2-100 ng/mL with LLOQ of 0.2 ng/mL. Pharmacokinetic parameters analyzed from the plasma samples and data from the reference and test drugs in the plasma were represented such as AUC(0-t) (142.31 vs 131.95 ng.h/mL), AUC(0-infinity) (143.85 vs 133.72 ng.h/mL), C-max(33.28 vs 30.46 ng/mL), T-max(2.0 vs 1.9 h), half-life(1.6 vs 1.6 h), extrapolation (1.35 vs 1.46%), and Ke (0.46 vs 0.45 h(-1)). Pharmacokinetic parameters with a 90% confidence interval (CI) were 0.873-1.084 for AUC(0-t) and 0.863-1.149 for C-max. Pharmacokinetic parameters with 90% CI were included within the bioequivalence range of 80-125% of the KFDA guidelines. Therefore, the two imidapril types were found to be bioequivalent during the fasting state in normal subjects.
URI
http://www.eurekaselect.com/133430/articlehttp://hdl.handle.net/20.500.11754/30314
ISSN
1573-4129; 1875-676X
DOI
10.2174/1573412911666150723232335
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
Files in This Item:
There are no files associated with this item.
Export
RIS (EndNote)
XLS (Excel)
XML


qrcode

Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.

BROWSE