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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. [Download Article] [Download Certifiate] |