Rapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studies

AuthorSeyed Mohsen Foroutanen
AuthorAfshin Zarghien
AuthorAlireza Shafaatien
AuthorBabak Madadianen
AuthorFarshid Abolfathien
Issued Date2013-03-31en
AbstractA 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.en
DOIhttps://doi.org/10.22037/ijpr.2013.1273en
KeywordClarithromycinen
KeywordPlasmaen
KeywordHPLCen
KeywordBioequivalencyen
KeywordPharmacokinetic studiesen
PublisherBrieflandsen
TitleRapid High Performance Liquid Chromatographic Method for Determination of Clarithromycin in Human Plasma Using Amperometric Detection: Application in Pharmacokinetic and Bioequivalence Studiesen
TypeOriginal Articleen

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