Paper Information

Title: 

AN ISOCRATIC HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR QUANTIFICATION OF CLOPIDOGREL CARBOXYLIC ACID IN HUMAN SERUM USING LIQUID-LIQUID EXTRACTION; APPLICATION TO A BIOEQUIVALENCE STUDY

Type: POSTER
Author(s): JAFARI Y.,GHIASI G.,MOHAMMADI B.,BAHRAMI GH.R.
 
 
 
Name of Seminar: IRANIAN CONGRESS OF PHYSIOLOGY AND PHARMACOLOGY
Type of Seminar:  CONGRESS
Sponsor:  PHYSIOLOGY AND PHARMACOLOGY SOCIETY, MASHHAD UNIVERSITY OF MEDICAL SCIENCE
Date:  2007Volume 18
 
 
Abstract: 

Introduction: Clopidogrel is an inhibitor of platelet aggregation however; the drug cannot be detected in the circulation following systemic administration. In the human pharmacokinetic studies inactive metabolite of the drug, clopidogrel carboxylic acid (CCA) is measured and considered as index of the drug bioavailability.
Methods: This study was aimed to develop an accurate and sensitive HPLC method for analysis of the drug metabolite following single dose administration. Sodium phenytoin was used as internal standard (I.S.) and the analytes were extracted from serum using ethyl acetate. A mixture of 0.05 M phosphate buffer containing triethylamine (0.5 ml L-1; pH= 5.8) and methanol (45:55; v/v) was used as mobile phase and chromatographic separation was achieved on a Shimpack CLC-ODS column at 225 nm.
Results: Under these conditions CCA and the I.S. were eluted with respective retention times of 3.2 and 5.1 min. The analytical method was linear over the concentration range of 0.02-20μg mL-1 of CCA in human serum with a limit of quantification of 0.02 μg mL-1.
Conclusion: The method validation was studied and the validated method showed excellent performance in terms of selectivity, specificity, sensitivity, precision and accuracy. This method was applied in a bioequivalence study following single dose administration of two different clopidogrel preparations in 24 healthy volunteers.

 
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