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用于药物制剂和生物体液中瑞舒伐他汀测定的分析方法: 批判性评价。

Analytical Methods for the Determination of Rosuvastatin in Pharmaceutical Formulations and Biological Fluids: A Critical Review.

机构信息

a Faculty of Pharmaceutical Sciences, Federal University of Alfenas , Alfenas , Minas Gerais , Brazil.

b School of Pharmaceutical Sciences of Ribeirão Preto, São Paulo University , Ribeirão Preto , São Paulo , Brazil.

出版信息

Crit Rev Anal Chem. 2018 Jul 4;48(4):317-329. doi: 10.1080/10408347.2018.1439364. Epub 2018 Mar 13.

DOI:10.1080/10408347.2018.1439364
PMID:29533074
Abstract

Rosuvastatin calcium (ROS), ( Figure 1 ) belongs to the "statins" group, which is the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor. This drug is indicated for dyslipidemias treatment and can help to decrease the level of "bad cholesterol" and can consequently reduce the development of atherosclerosis and the risk of heart diseases. ROS was developed by Astra-Zeneca and it was approved in 2003 by the FDA in the United States. In 2015, under the trade name Crestor®, it was the fourth largest selling drug in the United States with sales above $5 billion. This study presents a literature review of analytical methods for the quantification of ROS in pharmaceutical preparations and biological fluids. The major analytical methods described in this study for ROS were spectrophotometry, high-performance liquid chromatography (HPLC) coupled to ultraviolet (UV) detection, and tandem mass spectrometry (LC-MS/MS).

摘要

罗苏伐他汀钙(ROS)(图 1)属于“他汀类药物”,是 3-羟基-3-甲基戊二酰辅酶 A(HMG-CoA)还原酶抑制剂。该药用于治疗血脂异常,可降低“坏胆固醇”水平,从而减少动脉粥样硬化的发展和心脏病的风险。ROS 由阿斯利康开发,于 2003 年经美国 FDA 批准。2015 年,商品名为 Crestor®,是美国销售额超过 50 亿美元的第四大畅销药物。本研究对用于药物制剂和生物体液中 ROS 定量的分析方法进行了文献综述。本研究中描述的 ROS 的主要分析方法为分光光度法、高效液相色谱(HPLC)与紫外(UV)检测联用和串联质谱(LC-MS/MS)。

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