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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2004, Vol. 9 ›› Issue (7): 792-794.

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Determination of clarithromycin in human plasma by HPLC method and study of clarithromycin bioequivalence

ZHANG Hong, LI Hua1, LI Yan-Yan, XIONG Yu-Qing   

  1. Institute of Clinical Pharmacology, 1Laboratory of Biochemistry and Molecular Biology, J iangxi Medical College, Nanchang 330006, Jiangxi, China
  • Received:2004-06-07 Revised:2004-06-30 Online:2004-07-26 Published:2020-11-20

Abstract: AIM: To establish a HPLC method to determine the concentration of clarithromycin in human plasma, and to study clarithromycin bioequivalence by this method.METHODS: A HPLC assay was developed.Chromatographic assay was performed on a column of diamonsil C18 (4.6 mm×150 mm).The mobile phase was a mixture of acetonitrile and water (32∶68), the flow rate 1.0 ml·min-1, and the detection wavelength 210 nm.RESULTS: The calibration curve was linear in the range of 0.05 -3.2 mg·L-1.The minimum detection concentration was 0.05 mg·L-1.The values of AUC, Cmax, Tmaxand t12β of two preparations did not show significant difference (P>0.05).The relative bioavailability was (101.10 ±19.40) %.CONCLUSION: The proposed method can be applied to the assay of clarithromycin in reverse phase conditions easily and rapidly, and the two preparations of clarithromycin hydrochloride are bioequivalent.

Key words: solid-phase extraction, HPLC, clarithromycin, pharmacokinetics, bioavailibility, bioequivalent

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