Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROSCOPIC METHOD FOR RIVAROXABAN ANALYSIS IN BULK AND TABLET DOSAGE FORM

Vaishali K.*, Sowmya H. G. and Naveen Kumar G. S.

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Abstract

A novel, accurate, and efficient zero-order derivative UV spectroscopic method has been developed and validated for the quantification of Rivaroxaban in both bulk drug and pharmaceutical dosage forms. Rivaroxaban exhibits maximum absorbance at 277 nm in 0.1N Hcl, and its concentration follows Beer’s Law within the range of 2– 12 μg/mL. The method showed strong linearity, with a correlation coefficient (R²) of 0.9996, indicating high consistency and reliability across the studied range. Recovery rates were observed between 99.07%and 101.03%, while the limits of detection (LOD) and quantification (LOQ) were found to be 0.0458 μg/mL and 0.139 μg/mL, respectively. The method also demonstrated excellent precision, with relative standard deviation (%RSD) values below 2%. All validation parameters—linearity, accuracy, precision, robustness, ruggedness, LOD, and LOQ—were assessed according to ICH guidelines. This validated spectroscopic approach proves to be a dependable and reproducible method for routine analysis of Rivaroxaban in various pharmaceutical preparations.

Keywords: Rivaroxaban, Zero order derivative spectroscopy, Validation, Pharmaceutical formulations.