University Center of the North of Espirito Santo, UFES, BR 101 North, km 60, 29932-540 São Mateus, ES, Brazil.
Molecules. 2013 Jan 24;18(2):1447-56. doi: 10.3390/molecules18021447.
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.
阿托伐他汀是一种降脂药物，属于他汀类药物，其参比药物是辉瑞的立普妥®。它用于降低富含胆固醇的脂蛋白水平，降低冠心病的风险。众所周知，钙阿托伐他汀（ATV），C₆₆H₆₈CaF₂N₄O₁₀·3H₂O，具有多晶型性。生产仿制药的制药公司通常会寻找这种药物，因为这种药物价格高，在全球范围内使用，其专利已于 2010 年底到期。许多关于该药物药物范围的问题表明，它在稳定性研究和药物及药物制剂降解产物的鉴定方面非常重要。ATV 在酸性和碱性条件下会降解，包括在酸性条件下的一级动力学降解，而在碱性条件下的零级动力学降解，在酸性介质中研究时往往不太稳定。在酸性介质中降解的速率常数（k）为 1.88×10⁻² s⁻¹（一级），而在碱性介质中 k = 2.35×10⁻⁴ mol L⁻¹ s⁻¹（零级），表明药物在酸性介质中的稳定性较低。
