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Sci. Pharm. 2013, 81(1), 195-210; doi:10.3797/scipharm.1210-19

Comprehensive Assessment of Degradation Behavior of Aspirin and Atorvastatin Singly and in Combination by Using a Validated RP-HPLC Method

Department of Pharmaceutical Analysis, Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway, Ahmedabad, Gujarat, 382481, India
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Received: 18 October 2012 / Accepted: 11 December 2012 / Published: 11 December 2012
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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 compre-hensive 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 x 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.
Keywords: Aspirin; Atorvastatin; Chemical incompatibility; Degradation profile; Drug combination; HPLC; Acetylsalicylic acid Aspirin; Atorvastatin; Chemical incompatibility; Degradation profile; Drug combination; HPLC; Acetylsalicylic acid
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

SHERIKAR, O.; MEHTA, P. Comprehensive Assessment of Degradation Behavior of Aspirin and Atorvastatin Singly and in Combination by Using a Validated RP-HPLC Method. Sci. Pharm. 2013, 81, 195-210.

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