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J AOAC Int. 2018 Dec 18. doi: 10.5740/jaoacint.18-0200. [Epub ahead of print]

Atorvastatin: A Review of Analytical Methods for Pharmaceutical Quality Control and Monitoring.

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Univ Estadual Paulista - UNESP, School of Pharmaceutical Sciences of Araraquara, Department of Pharmaceutics, Araraquara, São Paulo, Brazil.
Centro Universitário Hermínio Ometto - FHO Uniararas, Specialization in Quality Control of Pharmaceutical Products, Araras, São Paulo, Brazil.


Background: Atorvastatin, a lipid-regulating drug, was the best-selling drug in the world in the early 2000s. Thus, monitoring of this drug is important because it is accessible to a large portion of the population. In addition, its quality control is fundamental to provide quality medicines. Method of analysis can be the first step in the rational use of pharmaceuticals. Objective/Methods: In this context, a critical review of analytical methods present in the literature and official compendia for the pharmaceutical quality control of atorvastatin was made. Results: Among the analytical methods most used in the evaluation of atorvastatin, HPLC is highlighted, followed by HPLC coupled to MS, and spectrophotometry in UV. Tablets are the most studied pharmaceutical samples, and plasma is the most studied biological matrix. In the literature, studies with atorvastatin-based pharmaceutical products are more common than biological materials. Acetonitrile is the organic solvent most commonly used in the methods surveyed to evaluate atorvastatin. Conclusions: Currently, awareness of the impact that the analytical choice has on the health of the operator and the environment is growing. Therefore, the suitability of existing methods for the determination of atorvastatin can be made to adhere to the current analytical chemistry. In this way, the analytical, environmental, and human consciousness will remain united. Highlights: Although the literature shows interesting methods from an economic and environmental point of view, such as UV, Vis miniaturized, and TLC, they can still be improved to meet the requirements of the current sustainable analytical chemistry.


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