UV Spectrophotometric Method Development and Validation of Darunavir in bulk and Solid Dosage Form

Tegeli, Varsha Birajdar Avinash Matole Vinod

Objective: A new, simple, sensitive, precise, reproducible UV visible spectrophotometric method was developed for the determination of Darunavir in Tablet dosage form with 0.1N HCl. Method: The method is based on the formation of a colorless complex. The UV spectrum of Darunavir in 0.1N HCl showed maximum wavelength at 298nm. Beer's law is valid in the concentration range of 10-60pg/ml. this method was validated for linearity, accuracy, precision, assay, ruggedness and robustness. Results: The method has demonstrated excellent linearity over the range of 10-60µg/ml with the regression equation y=0.0113x+0.0098, and regression coefficient i.e. r2=0.9992 moreover, the method was found to be highly sensitive with LOD (1.85µg/ml) and LOQ (5.62µg/ml). Conclusion: Based on the results the proposed method can be successfully applied for the assay of Darunavir in various tablet dosage forms.