Impurities profiling Method and degradation studies for Sumatriptan Succinate in Sumatriptan Succinate and Naproxen Sodium Tablets

Palavai Sripal reddy, Shakil S

Abstract

A simple, sensitive, and precise high performance liquid chromatographic method for the impurities profiling of Sumatriptan succinate in Sumatriptan and naproxen tablets has been developed, validated and used for the determination of impurities in commercial pharmaceutical products. The Impurities were well separated on a Waters Spherisorb ODS-1 column ( 250mm X 4.6mm, 5µm) by the gradient program using 0.05 M Phosphate buffer (pH 3.0), Acetonitrile and methanol at a flow rate of 1.0 mL min-1 with detection wavelength at 225 nm. The developed method was found to be specific, precise, linear, accurate, rugged and robust. LOQ Values for all the known impurities were below reporting thresholds.