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Abstract

ANALYTICAL METHOD VALIDATION FOR DETERMINATION OF RELATED SUBSTANCE IN PREGABALIN BY HPLC

Sagar VLN*, Sharma GVR and Bharat KB

ABSTRACT

High Performance Liquid Chromatography (HPLC) method validation was performed for the determination of related substance in pregabalin. The validation method utilizes an Inertsil ODS-4 (250X4.6mm), 5 μ column at ambient temperature, gradient elution with aqueous sodium phosphate buffer at pH 6.50±0.05, acetonitrile as the mobile phases.This study showed that pregabalin related substance peaks were well resolved from the pregabalin and found to be satisfactory.

Keywords: Related Substances,Pregabalin,Hplc.


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