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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