Forced Degradation Study for Simultaneous Quantification of Aspirin and Omeprazole in Pharmaceutical Dosage form by RP-HPLC

Aims: To study force degradation of aspirin and omeprazole simultaneously by RP-HPLC method

Study design: RP-HPLC method was used to measure % degradation.

Place and Duration of Study: Study was carried out at center of excellence, G.I.D.C., vapi-396195, Gujarat, India between June 2019 to march 2020.

Methodology: A force degradation study of aspirin and omeprazole was carried out simultaneously. The drugs were subjected to various degradation conditions like hydrolysis by acid and base, Oxidative degradation, and thermal degradation study.

Results: For acidic condition, the degradation was found to be 32.63 % for aspirin and 61.64 % for omeprazole. For basic condition, the degradation was found to be 10.17 % for aspirin and 4.29 % for omeprazole. By oxidative hydrolysis, the aspirin was degraded by 15.48 % and omeprazole was degraded by 26.38 %. By thermal degradation, 0.37 % degradation was observed for aspirin and 4.32 % degradation for omeprazole.

Conclusion: In this proposed method the retention time for drug is less than 8 min, which is less then available method. For omeprazole, strong degradation was observed in acidic conditions and mild in basic hydrolysis conditions. For aspirin, more degradation was observed in basic conditions than acidic hydrolysis. Both drugs were degraded in oxidative conditions using 3% H2O2. Omeprazole degraded more than aspirin by dry heat degradation. The method was successfully applied for the quantitative determination of both Active Pharmaceutical Ingredients.