Abstract

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.

Highlights

  • Myocardial Infarction occurs when blood flow stops to a part of the heart causing damage to the heart muscle [1]

  • Hen the concentration of a was increased and after 1 hour of heating with 0.5 a at 60 c temperature, around 10.17 % degradation was observed in aspirin (Fig. 6a) and 4.29 % degradation was observed in omeprazole. (Fig. 6b) So, in alkaline conditions, more degradation of aspirin was observed than omeprazole

  • Almost 8% degradation was obtained for aspirin (Fig. 7a) and 8 % for omeprazole (Fig. 7b) with 3% H2O2 at room temperature after 1 hour and 15% and 27% degradation were obtained for aspirin (Fig. 8a) and omeprazole (Fig. 8b) respectively after 3 hours at room temperature

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Summary

Introduction

Myocardial Infarction occurs when blood flow stops to a part of the heart causing damage to the heart muscle [1]. A fixed-dose combination is available containing the antiplatelet agent aspirin and the proton pump inhibitor omeprazole [2,3,4,5]. As per the literature survey, no reported method was found for the force degradation study of aspirin and omeprazole simultaneously. There was a method related to esomeprazole and aspirin but there is no actual degradation found simultaneously with aspirin. As per the reported article, there is a difference in the degradation of omeprazole and esomeprazole. The other methods were found for simultaneous estimations are UV [9], and HPLC [10], and some methods for omeprazole and aspirin separately

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