Foroutan, S., Zarghi, A., Shafaati, A., Madadadian, B., Abolfathi, F. (2013). Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies. Iranian Journal of Pharmaceutical Research, 12(Supplement), 65-69. doi: 10.22037/ijpr.2013.1273
Seyed Mohsen Foroutan; Afshin Zarghi; Alireza Shafaati; Babak Madadadian; Farshid Abolfathi. "Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies". Iranian Journal of Pharmaceutical Research, 12, Supplement, 2013, 65-69. doi: 10.22037/ijpr.2013.1273
Foroutan, S., Zarghi, A., Shafaati, A., Madadadian, B., Abolfathi, F. (2013). 'Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies', Iranian Journal of Pharmaceutical Research, 12(Supplement), pp. 65-69. doi: 10.22037/ijpr.2013.1273
Foroutan, S., Zarghi, A., Shafaati, A., Madadadian, B., Abolfathi, F. Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies. Iranian Journal of Pharmaceutical Research, 2013; 12(Supplement): 65-69. doi: 10.22037/ijpr.2013.1273
Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies
11- Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2- Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
21- Department of Pharmaceutical Chemistry, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2- Pharmaceutical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
3Noor Research and Educational Institute, Tehran, Iran.
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.
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