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

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).

Solubility Enhancement of a Poorly Water-Soluble Drug Using Hydrotropy and Mixed Hydrotropy-Based Solid Dispersion Techniques

“…Statins block 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, an enzyme that transforms HMG-CoA into mevalonic acid. In the manufacture of cholesterol, HMG-CoA reductase is a rate-limiting enzyme [ 11 ]. Because of its low solubility in water, rosuvastatin has poor solubility in gastrointestinal fluids, and its oral bioavailability is restricted to roughly 20% due to substantial first-pass metabolism [ 12 ].…”

ICH and US-FDA validated HPTLC methods with greenness assessments for the assay of mixtures prescribed in stroke prophylaxis: application to pharmaceutical preparations and human plasma

“…Most recent assays of ROS either alone or in combination with other drugs include reversed-phase high-performance liquid chromatography (RP-HPLC) in pharmaceutical preparations [, , , 24, 25, 26, 27] and biological fluids [27] and HPLC-MS/MS in both pharmaceutical preparations and biological fluids [27].…”

Analytical quality by design approach for estimating rosuvastatin calcium in pharmaceutical formulation by green HPLC method: Ecologically evaluated and stability-indicating

“…The outcome of literature review puts fourth numerous analytical methods like UV spectrophotometry, spectrofluorimetry, capillary zone electrophoresis, mercury drop electrode, highly sensitive enzyme linked immune sorbent assay, HPLC, high performance thin layer chromatography, and liquid chromatographic couples with tandem mass spectrophotometry [liquid chromatography-mass spectrometry (LC-MS)/MS] were reported for the assessment of RC as lone component and in combination with other drugs (Angelo et al, 2018;Rajput et al, 2018). The HPLC methods (Balakumar et al, 2013;Balanagamani et al, 2017;Caglar and Toker, 2013; Figure 2.…”