A VALIDATED STABILITY INDICATING UV-SPECTROPHOTOMETRIC SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND FENOFIBRATE IN BULK AND PHARMACEUTICAL FORMULATION
Keywords:Correlation coefficient , Detection limit, Precision, Pharmaceutical, Quantification limit, Spectrophotometric, Ultraviolet, λ max, % RSD
Objective: The present work deals with the development and validation of the absorbance ratio method for the estimation of rosuvastatin calcium and fenofibrate in bulk and pharmaceutical formulation. Studied forced degradation characteristics of bulk and pharmaceutical formulation as per stability guidelines.
Methods: The bulk and pharmaceutical formulation studied by the absorbance ratio method. It is the ratio of absorbances at two selected wavelengths. One wavelength is the isoabsorptive point and another wavelength is λ max of one of the components. From the overlay spectra of the two drugs, ROS and FEN showed the isoabsorptive point at 249.5 nm. The second wavelength used was 287 nm, which was the λ max of FEN.
Results: The drugs obeyed Beer's law and showed a good correlation. The correlation coefficient for the ROS was 0.999 and for FEN 0.999. The RSD for intraday precision was 0.57 for ROS and 0.057 for FEN. The interday precision was 0.05 for ROS and 0.03for FEN, respectively. The detection limit and quantification limit were found to be 0.048 and 0.14 μg/ml for ROS and 0.069 and 0.21μg/ml for FEN, respectively. More degradation was found in acid hydrolysis and photostability degradation.
Conclusion: A simple, precise, accurate, validated, stability-indicating method for simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and pharmaceutical formulation has been developed.
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