METHOD DEVELOPMENT AND VALIDATION OF ROFLUMILAST IN TABLET DOSAGE FORM BY UV SPECTROPHOTOMETRY

Analytical method development and validation play important roles in the discovery, development and manufacture of pharmaceuticals. A simple and reproducible UV ? spectrophotometric method for the quantitative determination of Roflumilast in tablet formulation was developed and validated in the present work. The parameters linearity, precision, accuracy was studied. Roflumilast has the maximum wavelength at 250 nm. Analytical calibration curves were linear within a concentration range from 2 to 35 ?g/ml. The developed method was applied directly and easily to the analysis of the pharmaceutical tablet preparations. %RSD was found to be less than 0.3. The result of analysis has been validated statistically. Hence the proposed method can be used for the reliable quantification of Roflumilast in tablet formulation.