QUANTITATIVE SIMULTANEOUS ESTIMATION OF ASPIRIN AND OMEPRAZOLE BY RP-HPLC METHOD IMPLEMENTING AQbD APPROACH IN PHARMACEUTICAL DOSAGE FORM

A simple, accurate, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the simultaneous determination of Aspirin (ASP) and Omeprazole (OMP). By using box benchen design method have been developed and optimized. Effective chromatographic separation achieved using C18 column (250 × 4.6 mm, 5 µm) as a stationary phase and mobile phase consisted of methanol: Disodium hydrogen phosphate buffer (68: 32 v/v), pH adjusted to 4.5 with phosphoric acid at a flow rate 1.15 mL/min at a detection wavelength of 280 nm. Analytical Quality by Design approach was applied to evaluate the effect of three factors are the volume of the organic phase in the mobile phase, pH of mobile phase and flow rate on chromatographic responses like retention time and tailing factor. The retention time of ASP and OMP were found to be 2.94 and 5.87 min respectively. Calibration curves were found to be linear over the concentration range of 10-60 µg/mL for ASP and 5-30 µg/mL for OMP. The % recovery of drugs by developed method was found in the range of 98 – 102%. The proposed method was found to be precise and robust. The method was successfully applied for the quantitative determination of ASP and OMP in the tablet dosage form.