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Quantification of etodolac in human plasma for pharmacokinetics and bioequivalence studies in 27 Korean subjects

Title
Quantification of etodolac in human plasma for pharmacokinetics and bioequivalence studies in 27 Korean subjects
Author
강주섭
Keywords
Bioequivalence; Etodolac; Internal standard; LC-MS/MS; NSAIDs; Pharmacokinetics
Issue Date
2017-01
Publisher
Bentham Science Publishers B.V.
Citation
Drug Metabolism Letters, v. 10, no. 4, page. 286-294
Abstract
Objective: We developed a simple and validated liquid chromatography tandem mass spectrometry(LC-MS/MS) for quantification of etodolac using pioglitazone as an internal standard (IS) to assess pharmacokinetics and to appraise bioequivalence of two formulations of etodolac (reference and tested) in 27 healthy Korean subjects. Methods: Isocratic mobile phase consisted of 10 mM ammonium formate and acetonitrile were used to separate the analytes on a Gemini C18 column. Also, analytes were analyzed by MS/MS in multiple reaction monitoring (MRM) mode using the transitions of (M+H) + ions, m/z 288.2 → 172.3 and m/z 357.1 → 134.2 for quantification of etodolac and IS each. The standard calibration curves displayed significant linearity within the range of 0.2-30.0 μg/mL (r 2 =0.9956, 1/x 2 weighting) with LLOQ of 0.1 μg/mL. Results: The retention times of etodolac and the IS were 0.77 min and 0.57 min each, indicating the high-throughput potential of the proposed method. The pharmacokinetic parameters were calculated from the plasma samples and data form the reference and test drugs were represented as follows; Area under plasma concentration-time curve (AUC t ) (78.03 vs. 84.00 μg×h/mL), AUC ∞ (86.67 vs. 93.92 μg×h/mL), maximal plasma concentration (C max ) (19.49 vs. 18.94 μg/mL), time for maximal concentrations (T max ) (2.13 vs. 2.26 h), Plasma elimination half-life (T 1/2 ) (8.12 vs. 8.47 h), elimination rate constant (λ z ) (0.0853 vs. 0.0818 h -1 ). Pharmacokinetic parameters with 90% confidence interval fall within the bioequivalence range of 80-125%. Conclusion: Thus, the new testified method was successfully applied for the pharmacokinetic and bioequivalence studies for two etodolac formulations. © 2016 Bentham Science Publishers.
URI
http://www.eurekaselect.com/149306/articlehttp://repository.hanyang.ac.kr/handle/20.500.11754/106048
ISSN
1872-3128
DOI
10.2174/1872312811666170116151004
Appears in Collections:
COLLEGE OF MEDICINE[S](의과대학) > MEDICINE(의학과) > Articles
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