A Novel and Sensitive Spectrophotometric Approach for Quantifying Vardenafil Hydrochloride Trihydrate in Tablets: Application to Dissolution Testing

Aims: To develop and validate a novel Zero-order Absorbance UV-Spectrophotometric method for the quantification of Vardenafil Hydrochloride Trihydrate in commercial tablets and its application for dissolution testing. Background: Erectile Dysfunction (ED) is a significant disorder affecting men's sexual health, with Vardenafil being a potent and selective inhibitor of phosphodiesterase type 5 (PDE5). Vardenafil is commonly used as an oral therapy for treating ED. Accurate and reliable methods for its quantification in pharmaceutical formulations and during dissolution tests are essential for quality control. Objective: To establish and validate a simple, accurate, precise, economical, and sensitive method for determining the concentration of Vardenafil hydrochloride trihydrate in commercial tablets and during dissolution tests using UV-Spectrophotometry. Method: A Zero-order Absorbance UV-Spectrophotometric approach was employed, utilizing 0.1N HCl as the solvent. The method was optimized to determine Vardenafil hydrochloride trihydrate within a linear range of 2-12 µg/mL, with a coefficient of correlation value greater than 0.99. The method was validated for accuracy, precision, sensitivity, and ruggedness according to ICH guidelines. Additionally, the method was applied for the quantification of Vardenafil hydrochloride trihydrate in dissolution tests. Result: The method successfully determined Vardenafil hydrochloride trihydrate concentration in commercial tablets, showing a % recovery between 99.85% and 100.07%. The % amount of drug estimated was in good agreement with the label claims. The method also allowed direct measurement of samples from the dissolution vessel without pH correction. Conclusion: The developed UV-Spectrophotometric method is a reliable, accurate, and cost-effective approach for quantifying Vardenafil hydrochloride trihydrate in commercial tablets and during dissolution tests. The method's validation as per ICH guidelines ensures its suitability for routine quality control. Other: This analytical approach provides the simple and economical technique for the analysis of Vardenafil hydrochloride in pharmaceutical formulation.