Analytical Method Development and Validation of RP-HPLC for Estimation of Roflumilast in Bulk drug and Tablet Dosage Form

Author(s)

Ladani, J. J., Bhimani, R. D., Vyas, K. B., Nimavat, K. S.

Author's Affiliation

Abstract

A new simple, specific, sensitive, rapid accurate and precise RP-HPLC method was developed for the estimation of Roflumilast in bulk and pharmaceutical formulation. Roflumilast was chromatographed on zorbex XDB C18 column (150 mm × 4.6 mm, 5µm) in a mobile phase consisting of mixture of ammonium acetate buffer and a solvent mixture (Acetonitrile : Methanol : 80 : 20) in the ration of 40:60v/v. The mobile phase was pumped at a flow rate of 1.0 ml/min with detection at 245 nm. The detector response was linear in the concentration of 1-15µg/ml. the intra and inter day variation was found to be less than 1.0%. The mean recovery of the drug from the solution was 100.1%. Hence it can be applied for routine quality control analysis of Roflumilast in bulk and pharmaceutical formulation.

Keywords

Roflumilast, RP-HPCL, Accuracy, Precision

Cite This Article

Ladani, J. J., Bhimani, R. D., Vyas, K. B., Nimavat, K. S. (2012). Analytical Method Development and Validation of RP-HPLC for Estimation of Roflumilast in Bulk drug and Tablet Dosage Form, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(3), 28-32.