Development and Validation of Analytical Method for Estimation of Aspirin and Dipyridamole in Their Fixed Combine Dosage Form

Abstract

The aim of current Research work was to develop a validated simple and precise stability indicating RP-HPLC method for development of Aspirin and Dipyridamole in their fixed combine dosage form. Chromatographic separation of aspirin and dipyridamole was obtained on Zorbax SB C8, (250 x 4.6) mm, 5μm column using a gradient method with combination of mobile phase-A containing Buffer (pH 3.5 adjust with orthophosphoric acid): Acetonitrile (750:250), mobile phase-B containing Buffer (pH 3.5 adjust with orthophosphoric acid): Acetonitrile (250:750) and flow rate 1.5ml/min. Detection and quantification was done at wavelength are 230 nm using UV detector. Liner relationship was observed in method for concentration range 1.0-30.10 μg/ml and for dipyridamole 7.93-237.89 μg/ml with correlation coefficient of 0.99992 for both drugs. Different Stress Conditions were applied on the developed method such as Acid degradation, Base degradation, Peroxide degradation, Thermal degradation, Humidity degradation and degradation product has been found during the estimation of Aspirin and Dipyridamole. Developed method has not shown any interference during different stress conditions. The method for analysis of aspirin and dipyridamole was found to be accurate and precise with average recovery 98.0-102.0%. The proposed method was found suitable for the routine quantitative analysis of aspirin and dipyridamole in Extended-Release capsule.