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

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ÇAĞLAR ANDAÇ S., TOKER S., ERGİN KIZILÇAY G., ÖZDEMİR E.

Istanbul Journal of Pharmacy, cilt.54, 2024 (ESCI, TRDizin)

Özet

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.