rapid high performance liquid chromatographic method for determination of clarithromycin in human plasma using amperometric detection: application in pharmacokinetic and bioequivalence studies

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 acetonitrile- methanol-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.