Abstract

VALIDATED SPECTROPHOTOMETRIC METHOD FOR THE QUANTITATION OF FLUVOXAMINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

Umme Kulsum* and Naveen Kumar G. S.

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Abstract

Simple, precise and accurate zero-order derivative UV spectroscopic method has been developed and validated for the estimation of Fluvoxamine in bulk and pharmaceutical dosage form. Fluvoxamine exhibits maximum absorbance at 256 nm in Ethanol, and its concentration follows Beer’s Law within the range of 5–30 μg/ml. The linearity study was carried out and regression coefficient (R²) was found to be 0.999 and it has showed good linearity, precision during this concentration range. The percentage recovery was found to be 98.8% and 101.39%, while the limits of detection (LOD) and quantification (LOQ) were found to be 0.049 μg/ml and 0.150 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. The developed and validated method can be successfully applied for routine estimation of Fluvoxamine in bulk and pharmaceutical dosage form.

Keywords: Fluvoxamine, Zero order derivative spectroscopy, Validation, Pharmaceutical formulation.