Abstract
Studies were carried out to investigate the charge-transfer (CT) reaction of ROS-Ca, as a n-electron donor with various π-acceptors: tetracyanoethylene, p-chloranilic acid, 2,3-dichloro-5,6-dicyano-1,4-benzoquinone, 2,3,5,6-tetrabromo-1,4-benzoquinone, 1,3,5-trinitrobenzene, 2,3,5,6-tetrachloro-1,4-benzoquinone, 7,7,8,8-tetracyano-quinodimethane, and 2,4,7-trinitro-9-fluorenone. Different colored CT complexes were obtained. The reaction mechanism and site of interaction were determined by ultraviolet-visible spectrophotometric techniques and computational molecular modeling. The formation of the colored complexes was utilized in the development of simple, rapid and accurate spectrophotometric methods for the determination of ROS-Ca. Under the optimum reaction conditions, linear relationships with good correlation coefficients (0.9984–0.9995) were found between the absorbances and the concentrations of ROS-Ca in the range of 2–200 μg mL−1. The limits of detection ranged from 0.41 to 12.24 μg mL−1. No interference could be observed from the additives commonly present in the tablets or from the drugs that are co-formulated with ROS-Ca in its combined formulations. The methods were successfully applied to the analysis of tablets with good accuracy and precision; the recovery percentages ranged from 99.54–100.46 ± 1.58–1.82%. The results were compared favorably with the reported method. The proposed methods are practical and valuable for routine application in quality control laboratories for determination of ROS-Ca in its bulk form and tablets.
Highlights
Rosuvastatin calcium (ROS-Ca, bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)-amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt, Figure 1) is a synthetic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor
Spectrophotometric method for determination of ROS-Ca is required as an alternative for High performance liquid chromatography (HPLC)
The resulting maxima of ROS-Ca with DDQ (Figure 3), bromanil, chloranil (Figure 5), and TNF are similar to that of radical anions of these acceptors obtained by the reduction method and coincide with the values reported in the literature [27,28]
Summary
Rosuvastatin calcium (ROS-Ca, bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)-amino] pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid calcium salt, Figure 1) is a synthetic 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor It exerts its action by inhibiting the HMG-CoA reductase, the enzyme that catalyzes the conversion of HMG-CoA to mevolanate, which is the early rate-limiting step in the biosynthesis of cholesterol in the body. A literature survey revealed that several analytical methods were reported for ROS-Ca determination. Spectrophotometry is the most widely used technique in pharmaceutical analysis because of its inherent simplicity and wide availability in most quality control laboratories [8,9,10,11,12,13] For these reasons, spectrophotometric method for determination of ROS-Ca is required as an alternative for HPLC. The CT-reaction as a basis for the development of new spectrophotometric methods for determination of ROS-Ca
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