Quantitative determination of azithromycin in human plasma by liquid chromatography-mass spectrometry and its application in a bioequivalence study
| Autor: | Ben-Mei Chen, Ping Zhou, Xiang Chen, Fu-Liang Deng, Shao-Gang Liu, Yi-Zeng Liang |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male Electrospray Spectrometry Mass Electrospray Ionization Electrospray ionization Clinical Biochemistry Pharmaceutical Science Administration Oral Bioequivalence Azithromycin Mass spectrometry Analytical Chemistry Liquid chromatography–mass spectrometry Clarithromycin Drug Discovery Humans Spectroscopy Chromatography High Pressure Liquid Antibacterial agent Detection limit Chromatography Chemistry Elution Reproducibility of Results Anti-Bacterial Agents Therapeutic Equivalency |
| Zdroj: | Journal of pharmaceutical and biomedical analysis. 42(4) |
| ISSN: | 0731-7085 |
| Popis: | A sensitive, rapid liquid chromatographic-electrospray ionization mass spectrometric method for determination of azithromycin in human plasma was developed and validated. Azithromycin in plasma (0.2mL) was extracted with methyl tert-butyl ether-hexane (50:50, v/v), organic phase was transferred to another clear 1.5mL Eppendorf tube and evaporated to dryness at 40 degrees C and dissolved in mobile phase, samples were separated using a Thermo Hypersil HyPURITY C18 reversed-phase column (150mmx2.1mm i.d., 5microm), together with a mobile phase containing of 20mM ammonium acetate (pH 5.2)-acetonitrile-methanol (50:40:10, v/v/v) and was isocratically eluted at a flow rate of 0.2mL/min. Azithromycin and its internal standard, clarithromycin, were measured by electrospray ion source in positive selective ion monitoring mode. The method demonstrated that good linearity ranged from 2 to 1000ng/mL with r=0.9977. The limit of quantification for azithromycin in plasma was 2ng/mL with good accuracy and precision. The higher mean extraction recovery, say 81.2% and 75.5% for azithromycin and internal standard (IS), respectively, was obtained in this work. The intra-day and inter-day precision ranged from 4.8% to 8.6% and 6.4% to 10.7% (R.S.D.), respectively. The established method has been successfully applied to bioequivalence study of 2 azithromycin formulations for 24 healthy volunteers. |
| Databáze: | OpenAIRE |
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