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

Year 2024, Volume: 54 Issue: 3, 476 - 482, 30.12.2024

Sena Çağlar Andaç , Sıdıka Ertürk Toker , Gamze Ergin Kızılçay , Elif Özdemir

https://doi.org/10.26650/IstanbulJPharm.2024.1515450

Abstract

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.

Keywords

Derivatization, Fluorescence, HPLC, Rosuvastatin, Statin, Tablet

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