A Sensitive Liquid Chromatographic Method for the Analysis of Clarithromycin with Pre-Column Derivatization: Application to a Bioequivalence Study
Publish place: Iranian Journal of Basic Medical Sciences، Vol: 12، Issue: 1
Publish Year: 1388
نوع سند: مقاله ژورنالی
زبان: English
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شناسه ملی سند علمی:
JR_IJBMS-12-1_004
تاریخ نمایه سازی: 30 مهر 1400
Abstract:
Objective(s) A sensitive liquid chromatographic method for the analysis of clarithromycin- a macrolide antibiotic- in human serum, using pre-column derivatization with ۹-fluorenylmethyl chloroformate (FMOC-Cl) is described. Materials and Methods The method involved liquid-liquid extraction of the drug and an internal standard (amantadine) followed by pre-column derivatization of the analytes with FMOC-Cl. A mixture of ۰.۰۵ M phosphate buffer containing triethylamine (۲ ml/l; pH ۳.۸) and methanol (۱۷:۸۳, v/v) was used as mobile phase and chromatographic separation was achieved on a Shimpack CLC-ODS column. The eluate was monitored by a fluorescence detector with respective excitation and emission wavelengths of ۲۶۵ and ۳۱۵ nm. Results The analytical method was linear over the concentration range of ۰.۰۲۵-۱۰ pg/ml of clarithromycin in human serum with a limit of quantification of ۰.۰۲۵ pg/ml. The assay is sensitive enough to measure drug levels obtained in human single dose studies. Conclusion In the present method, sensitivity and the running time of analysis have been improved and successfully applied in a bioequivalence study of three different clarithromycin preparations in ۱۲ healthy volunteers.
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Authors
Amir Farshchi
School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran
Golbarg Ghiasi
School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran
Gholamreza Bahrami
School of Pharmacy, Kermanshah University of Medical Sciences, Kermanshah, Iran
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