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Abstract
A fixed-dose combination of atorvastatin and aspirin is widely used for the treatment of myocardial infarction. The present work describes a comprehensive study of the stress degradation behavior of atorvastatin and aspirin alone as well as in combination of 1:1 and 1:7.5 ratios, respectively, as per ICH guidelines. The degradation products of aspirin as well as atorvastatin were successfully separated by a developed simple, selective, and precise stability-indicating reversed-phase HPLC method. Chromatographic separation was achieved on the Phenomenex Luna analytical column, 150 mm × 4.6 mm, 5μm. The mobile phase consisted of 0.1% glacial acetic acid in water and acetonitrile in the ratio of 50:50 v/v at a flow rate of 1.0 ml/min. UV detection was performed at 246 nm. The extent of degradation was significantly influenced when both of the drugs were present in combination. Stress degradation behavior of atorvastatin was highly influenced by aspirin under acid hydrolysis, thermal degradation, and oxidative stress conditions. Similarly, the stress degradation behavior of aspirin was affected by atorvastatin especially under neutral hydrolysis, thermal degradation, and oxidative stress conditions. Additionally, the combination ratio of aspirin and atorvastatin also influenced the percentage degradation of each other. A mixture of aspirin and atorvastatin was also analyzed after a one-month stability study at 40 °C and 75% RH. All the results indicate chemical incompatibility of both aspirin and atorvastatin if present in combination.
Highlights
The main cause of myocardial infarction (MI) is the interruption of the blood supply to the heart, which is most commonly due to the blockage of a coronary artery due to a hyperlipedemic condition
To get the maximum response of analyte by this method, 246 nm was used as the detection wavelength for both drugs, which is the absorption maxima of Atorvastatin calcium (ATR), and a promising response of ASP was obtained
The results obtained from the degradation studies showed that the developed stability-indicating assay method is specific towards ASP, ATR and their degradation products
Summary
The main cause of myocardial infarction (MI) is the interruption of the blood supply to the heart, which is most commonly due to the blockage of a coronary artery due to a hyperlipedemic condition. For the mitigation of such a condition, lipid lowering agents are widely used alone or in combination with other antihypertensive agents or with aspirin. Several fixed-dose combinations (FDCs) have been approved by the Food and Drug Administration (FDA) along with a combination of ATR and ASP due to their effectiveness against this condition [1, 2]. Atorvastatin calcium (ATR) is an antihyperlipidemic agent. It lowers lipid levels by inhibiting HMG-CoA reductase, a rate-limiting enzyme in cholesterol biosynthesis in the liver, reducing the cholesterol content in hepatocytes. ATR is chemically (3R,5R)-7-[2-(4fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid (Fig. 1a) [3, 4]
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