A Novel RP-HPLC Method for the Quantification of Roflumilast in Formulations

simple, precise and accurate RP-HPLC method was developed and validated for rapid assay of Roflumilast tablet dosage form. Isocratic elution at a flow rate of 1.0ml/min was employed on a symmetry Chromosil C18 (250x4.6mm, 5μm in particle size) at ambient temperature. The mobile phase consisted of Methanol: Acetonitrile 25:75 v/v. The UV detection wavelength was 244 nm and 20μl sample was injected. The retention time for Roflumilast was 4.4 min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Roflumilast tablet dosage form and bulk drug.