Author/Authors :
Foroutan, Mohsen Pharmaceutical Sciences Research Center - Shahid Beheshti University of Medical Sciences, Tehran - Department of Pharmaceutics - School of Pharmacy - Shahid Beheshti University of Medical Sciences, Tehran , Zarghi, Afshin Pharmaceutical Sciences Research Center - Shahid Beheshti University of Medical Sciences, Tehran - Department of Pharmaceutical Chemistry - School of Pharmacy - Shahid Beheshti University of Medical Sciences, Tehran , Shafaati, Alireza Pharmaceutical Sciences Research Center - Shahid Beheshti University of Medical Sciences, Tehran - Department of Pharmaceutical Chemistry - School of Pharmacy - Shahid Beheshti University of Medical Sciences, Tehran , Madadian, Babak Noor Research and Educational Institute, Tehran , Abolfathi, Farshid Noor Research and Educational Institute, Tehran
Abstract :
A rapid, sensitive and reproducible HPLC method using amperometric detector was
developed and validated for the analysis of clarithromycin in human plasma. The separation was achieved on a monolithic silica column (MZ- C8 125×4.0 mm) using acetonitrilemethanol- potassium dihydrogen phosphate buffer (40:6:54,v/v), with pH of 7.5, as the mobile phase at a flow rate of 1.5 mL/min. The assay enables the measurement of clarithromycin for therapeutic drug monitoring with a minimum quantification limit of 20 ng/mL. The method involves simple, protein precipitation procedure and analytical recovery was complete. The calibration curve was linear over the concentration range of 0.1-6 μg/mL. The coefficients of variation for inter-day and intra-day assay were found to be less than 6%. This method was used in bioequivalency and pharmacokinetic studies of the test (generic) product 2 × 500 mg
clarithromycin tablets, with respect to the reference product.
Keywords :
Clarithromycin , Plasma , HPLC , Bioequivalency , Pharmacokinetic studies
