RAPID SIMULTANEOUS ESTIMATION OF SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM IN TABLET DOSAGE FORMS USING A VALIDATED STABILITY- INDICATING MONOLITHIC LC METHOD

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 separation was achieved on a Kromosil -ODS C_(18)(250 X 4.6 mm; 5 u) column in an isocratic mode. The mobile phase was composed of water (HPLC grade) (45 %) (pH adjusted to 2.5 using ortho phosphoric acid) and methanol (55 %). The flow rate was monitored at 1.0 mL/min. The wavelength selected for detection was 277 nm. The retention time 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 ug/mL for both sumatriptan and naproxen. The limit for detection for sumatriptan and naproxen was 0.56 and 0.57 mug/mL, respectively. The limit of quantification for sumatriptan and naproxen was 1.69 and 1.74 mug/mL, respectively. Minor peaks were observed due to degradation of the drugs in the experiment (acid, alkali, thermal and photolytic degradation). However, these peaks did not interfere with those of the pure drugs. This indicates that the proposed method is specific. The proposed method was adequately sensitive, reproducible and specific for the determination of sumatriptan and naproxen in bulk as well as in tablet dosage forms.