DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF TADALAFIL IN BULK AND FORMULATION

Abstract

Objective: A new simple, sensitive, precise and reproducible spectroscopic method was developed for the determination of Tadalafil in Pharmaceutical formulation with Dimethyl Sulfoxide. Methods: The UV spectrum of Tadalafil in Dimethyl sulfoxide (DMSO) showed λ max at 285.6 nm. Beer’s law is valid in the concentration range of 10-60µg/ml. This method was validated for linearity, accuracy, precision, ruggedness and robustness. Results: The method was demonstrated excellent linearity over the range of 10-60µg/ml with regression equation y= 0.0337x-0.1343 and regression correlation R2= 0.998. Moreover, the method was found to be highly sensitive with LOD (2.44µg/ml) and LOQ (7.40µg/ml). Conclusion: Based on results, the proposed method can be successfully applied for assay of Tadalafil in various pharmaceutical dosage forms.