Highly sensitive carboxyl group fluorimetric derivatization HPLC analysis for rosuvastatin content in tablets

Background and Aims: The powerful antihyperlipidemic drug rosuvastatin blocks 3-hydroxy-3-methylglutaryl coenzyme A reductase, which is essential for cholesterol formation. Statins are a more recent class of antihyperlipidemic medications. Accurate quantification methods are crucial because of low rosuvastatin levels in tablets. The following the International Conference on Harmonisation (ICH) guidelines, a sensitive and high-performance liquid chromatographic approach was established in this study for the accurate determination of rosuvastatin in tablet formulations using spectrofluorimetric detection. Methods: The procedure requires one hour at room temperature and dark interaction between the acid group of rosuvastatin and the reagent 9-anthryldiazomethane. A C18 column (250 x 4.6 mm, 4 μm) was used for the gradient elution of an acetonitrile-water solution at a flow rate of 1.0 mL/min to achieve chromatographic separation. The internal reference was lovastatin. The excitation and emission wavelengths used for the detection were 366 and 410 nm, respectively. Results: Calibration curves for standard solutions were established by plotting the ratio of concentration to peak area over the range 0.01–20.0 ng/mL. The limits of quantification (LOQ) and detection (LOD) were 0.0068 and 0.0023 ng/mL, respectively. The relative standard deviation values for interday and intraday measurements of the standard solutions ranged from 0.24% to 3.76%. The mean recoveries for 0.240. in the tablet formulation were calculated as 98.0-99.9%. Conclusion: The developed method was used to determine the amount of rosuvastatin in tablets, and the results were compared with a 95% confidence level to those obtained using a literature method. The suggested approach works well for sensitive routine analysis and monitoring of drugs at low concentrations to investigate their bioavailability and bioequivalence.