Author(s): Gokulapriya A, Vetrichelvan T and Murugan S

Abstract: Novelty: Endoxifen citrate was quantified utilizing zero-order and first-order derivative approaches in a straightforward, quick, and affordable UV spectrophotometric method. To the best of our knowledge, no such analytical method has been previously reported for the estimation of this drug in bulk and tablet dosage form. Objective: To develop and validate a novel UV spectrophotometric method for Endoxifen citrate quantification as per ICH guidelines. Method: Distilled water was used as the solvent for the analysis, and the absorbance was maximum at 227 nm (zero order) and 211 nm (first order). Linearity was observed between 24-72 µg/mL. Forced degradation was studied under acidic, basic, oxidative, reductive, and thermal conditions. Results: Excellent linearity (r² = 0.9997 and 0.9999), accuracy (98.12-100.39 %), and precision (%RSD < 1.5 %) were achieved. The drug degraded only under acidic conditions. Conclusion: The suggested approach is appropriate for routine estimation of endoxifen citrate in pharmaceutical formulations since it is straightforward, accurate, exact, and cost-effective.

Pages: 113-119 | Views: 47 | Downloads: 21

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