RAPID HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF CLARITHROMYCIN IN HUMAN PLASMA USING AMPEROMETRIC DETECTION: APPLICATION IN PHARMACOKINETIC AND BIOEQUIVALENCE STUDIES

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FOROUTAN SEYYED MOHSEN; ZARGHI AFSHIN; SHAFAATI ALIREZA; MADADIAN BABAK; ABOLFATHI FARSHID

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Journal Paper

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Journal: Iranian Journal of Pharmaceutical Research Year:2013 | Volume:12 | Issue:SUPPLEMENT 1 Page(s): 65-69

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Title

RAPID HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF CLARITHROMYCIN IN HUMAN PLASMA USING AMPEROMETRIC DETECTION: APPLICATION IN PHARMACOKINETIC AND BIOEQUIVALENCE STUDIES

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Keywords

CLARITHROMYCIN

PLASMA

HPLC

BIOEQUIVALENCY

PHARMACOKINETIC STUDIES

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 1254.0 mm) using acetonitrile-methanol-potassium dihydrogen phosphate buffer (40: 6: 54, v/v), with pH of 7.5, as the mobilephase 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 mg/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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