An analytical method development and validation for simultaneous estimation of Sumatriptan and Naproxen in bulk samples as well as in tablet dosage forms by using RP-HPLC

摘要

The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The HPLC separation was achieved on a Kromosil -ODS C18 (250 X 4.6 mm; 5 μ) column in an Isocratic Mode. The mobile phase composed of Water [HPLC Grade] (45 %) [pH 2.5 adjusted with OPA] and Methanol (55 %). The flow rate was monitored at 1.0 mL/min. The wavelength was selected for the detection was 277 nm. The retention times found for Sumatriptan and Naproxen was 2.790 and 3.481 min respectively. The % recovery was 99.02- 100.75 for Sumatriptan and 99.85 - 100.22 for Naproxen. The linearity was established in the range of 20-80 μg/mL for both Sumatriptan and Naproxen. The LOD for Sumatriptan and Naproxen were 0.56 and 0.57 μg/mL respectively. The LOQ for Sumatriptan and Naproxen were 1.69 and 1.74 μg/mL respectively. The proposed method was adequate sensitive, reproducible, and specific for the determination of Sumatriptan and Naproxen in bulk as well as in tablet dosage forms.