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

Volume: 12 Issue: 2

Author(s): Su-Hee Lee, Hyun-Jin Kim, Shin-Hee Kim, Yoo-Sin Park, Min-A Kang, Do-Wan Kim and Ju-Seop Kang

Affiliation:

Keywords: Angiotensin-converting enzyme (ACE) inhibitor, bioequivalence, imidapril, korean volunteers, LC-MS/MS, Pharmacokinetics.

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 sample 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.

Cite this article as:

Lee Su-Hee, Kim Hyun-Jin, Kim Shin-Hee, Park Yoo-Sin, Kang Min-A, Kim Do-Wan and Kang Ju-Seop, Quantification of Imidapril in Human Plasma using the LC-MS/MS Method for Bioequivalence and Pharmacokinetic Studies, Current Pharmaceutical Analysis 2016; 12 (2) . https://dx.doi.org/10.2174/1573412911666150723232335