DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF ELETRIPTAN IN ELETRIPTAN HYDROBROMIDE ORALLY DISINTEGRATING TABLETS

A simple, precise, rapid and accurate stability indicating reverse phase high performance liquid chromatography has been developed and validated for the estimation of Eletriptan Hydrobromide in tablet dosage form. Separation was carried on a Waters e 2695 HPLC system separation module with Empower 2 software, PDA detector waters 2998 and Thermo-C18 analytical column (5µm; 150x4.6mm), was operated in isocratic mode using mobile phase consisting of (methanol and water in the ratio of 35:65) is used in the ratio of 35:65 and at a flow rate of 1ml/min with detection wavelength of 227 nm by an injection volume of 20µl and entire separation was carried out at 35°C column temperature. The linearity was found in the range of 5.0-500.0 µg/ml and showed a correlation co-efficient of 0.9999. The retention time of Eletriptan Hydrobromide was found to be 7.0. This study concluded that the proposed method was found to be accurate, reproducible and consistent which is useful for the routine determination of Eletriptan in tablet dosage form. The method is validated as per ICH guidelines by determining its specificity, accuracy, precision, linearity & range, ruggedness, robustness and system suitability