Abstract
Atorvastatin is an antilipemic drug belonging to the statins class, whose reference drug is Pfizer’s Lipitor®. It is used to reduce the levels of lipoproteins rich in cholesterol and reduce the risk of coronary artery disease. It is well-known that calcium atorvastatin (ATV), C66H68CaF2N4O10•3H2O, presents polymorphism. The drug in question is commonly sought after by pharmaceutical industries that produce generic drugs, due to the fact that the drug has a high value price, it is consumed globally, and its patent expired in late 2010. Many questions concerning this drug’s pharmaceutical scope demonstrate its importance regarding stability studies and the identification of degradation products of drugs and pharmaceutical formulations. ATV has been found to degrade under acid and basic conditions, including a first order kinetic degradation under acid conditions, as compared to a zero order kinetic degradation under basic conditions, which tends to be less stable when studied within acid mediums. The rate constant (k) for degradation in acid medium was 1.88 × 10−2 s−1 (first order), while for basic medium k = 2.35 × 10−4 mol L−1 s−1 (zero order), demonstrating a lower stability of the drug within acid mediums.
Highlights
Lipitor®, the commercial brand name of atorvastatin, was the best selling drug in the World from 2002 to 2009, generating a gross revenue of approximately 9.3 billion dollars
The high performance liquid chromatography (HPLC)/UV-DAD method was validated for atorvastatin, which included: a capacity factor (k’)
After having been submitted to stress conditions, the samples were analyzed by HPLC
Summary
Lipitor®, the commercial brand name of atorvastatin, was the best selling drug in the World from 2002 to 2009, generating a gross revenue of approximately 9.3 billion dollars. Atorvastatin calcium (ATV) is used to reduce the levels of lipoproteins rich in cholesterol and reduce the risk of coronary artery disease This is due to this drug’s inhibitory action on the hydroxymethylglutaryl-CoA reductase (HMG-CoA reductase) enzyme, which is important in cholesterol biosynthesis [2]. The drug is insoluble in aqueous solutions with pH ≤ 4.0; very slightly soluble in water, phosphate buffer (pH 7.4) and acetonitrile; slightly soluble in ethanol; and very soluble in methanol [3,4]. It is well-known that the drug presents polymorphisms [5,6]. The intrinsic stability and kinetic studies are fundamental elements in the search for possible degradation products of drugs; these products do not commonly appear under normal drug storage conditions
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