ASSESSMENT OF PERCENTAGE RECOVERY STUDY OF TETRABENAZINE AND ITS PHARMACEUTICAL DOSAGE FORMS BY UV

Spectroscopy is a fundamental analytical technique that examines the interaction between electromagnetic radiation and matter and is extensively applied in pharmaceutical analysis for both qualitative and quantitative purposes. Among various spectroscopic techniques, ultraviolet–visible (UV–Vis) spectroscopy is widely employed due to its simplicity, rapid analysis, accuracy, and cost-effectiveness. The present study was aimed at the development and validation of a simple, precise, and economical UV spectrophotometric method for the quantitative estimation and percentage recovery assessment of tetrabenazine in pharmaceutical dosage forms. Tetrabenazine, a vesicular monoamine transporter-2 (VMAT2) inhibitor used in the treatment of chorea associated with Huntington’s disease, requires accurate dosage determination due to its narrow therapeutic index. Pre-formulation studies were carried out to evaluate the physicochemical properties of the drug, including organoleptic characteristics, melting point, solubility, pH, and compatibility. Tetrabenazine exhibited good solubility in ethanol, which was selected as the analytical solvent. UV spectroscopic analysis revealed a maximum absorbance (λmax) at 350 nm. The method demonstrated excellent linearity in the concentration range of 20–120 µg/mL with a correlation coefficient (R²) of 0.9999, confirming compliance with Beer–Lambert’s law. The developed method was validated in accordance with ICH guidelines for specificity, linearity, accuracy, precision, ruggedness, robustness, limit of detection, and limit of quantitation. The percentage recovery of approximately 98% indicated good accuracy, while %RSD values below 2% confirmed precision and reproducibility. The validated UV spectrophotometric method is reliable, rapid, and suitable for routine quality control analysis of tetrabenazine in bulk drug and tablet dosage forms.