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Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHD FOR THE ASSAY OF CLARITHROMYCIN IN BULK AND FORMULATION

Hanaa Khayoon Shalf*

ABSTRACT

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Clarithromycin (CLA). The flow rate was 1.0 mL/min and the eluents were detected by UV detector at 205 nm. The retention times were found to be 2.21 and 3.73 mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75– 175 μg/mL for both drugs. The developed method was applied successfully for assay of Clarithromycin in their combined in-house developed dosage forms and in vitro dissolution studies.

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