Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies
Author | Seyed Mohsen Foroutan | en |
Author | Afshin Zarghi | en |
Author | Alireza Shafaati | en |
Author | Babak Madadian | en |
Author | Farshid Abolfathi | en |
Issued Date | 2013-03-31 | en |
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 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. | en |
DOI | https://doi.org/10.22037/ijpr.2013.1273 | en |
Keyword | Clarithromycin | en |
Keyword | Plasma | en |
Keyword | HPLC | en |
Keyword | Bioequivalency | en |
Keyword | Pharmacokinetic studies | en |
Publisher | Brieflands | en |
Title | Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies | en |
Type | Original Article | en |
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