Rapid Simultaneous Determination of Sumatriptan Succinate and Naproxen Sodium in Combined Tablets by Validated Ultra Performance Liquid Chromatographic Method

Abstract

A stability- indicating ultra perfomance liquid chromatography (UPLC) method was developed for the simultaneous determination of sumatriptan succinate and Naproxen sodium in pharmaceutical dosage forms. The chromatographic separation was achieved on C18, 50 mm × 4.8 mm, 1.8-μm particle size column. The mobile phase contains a mixture of 0.2% ortho phosphoric acid and acetonitrile as the mobile phase in gradient elution technique. The retention time of Sumatriptan and Naproxen was found to be 1.7 and 2.7 min respectively. The total runtime was 5 min within which two active compounds and degradation products were separated. This method allows the determination of 850-2565 μg mL -1 of sumatriptan succinate and 5000-15000 μg mL -1 of Naproxen sodium. The flow rate was 1.0 mL min -1 and the detection wavelength was 225 nm. The limit of detection (LOD) for sumatriptan succinate and Naproxen sodium was 1.9 and 1.5 μg mL -1 , respectively. The limit of quantification (LOQ) for sumatriptan succinate and Naproxen sodium was 6.3 and 4.8 μg mL -1 , respectively. This method was validated for accuracy, precision, linearity and robustness. sumatriptan succinate and Naproxen sodium were subjected to different ICH prescribed stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation and the method was also found to be stability indicating.