Development and validation of stability indicating RP-HPLC method for estimation of roflumilast in tablet dosage form
Avula Pooja1, Galla Rajitha1*, Adepu Geetha Susmita1, Vemanaboina Hari Babu2, Tyagarajan Sivaranjani2
1Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam (Women's University), Tirupati.
2Analytical Development (AR&D), Orchid Health Care, IKKT, Chennai
*Corresponding Author E-mail: firstname.lastname@example.org
Online published on 30 April, 2021.
A simple, precise, stable and economical RP-HPLC method was developed for estimation of Roflumilast in tablet dosage form and validated according to the ICH guidelines. The chromatographic separation was achieved on an Inertsil ODS-3V column of dimensions 150mm x 4.6mm, 5μm, using a mobile phase mixture of 0.01M ammonium acetate buffer and organic mixture (methanol: acetonitrile in 1: 1 ratio) in the ratio of 25: 75 (v/v) at a flow rate of 1.5ml/min and UV detection at 250nm. The injection volume was maintained at 80μl with 6 min run time. Retention time (RT) was found to be 2.92±0.01min. This developed method was validated as per the ICH guidelines. Linear plot was obtained with a correlation coefficient of 0.999 in the concentration range of 5–40 μg/ml. The optimized method was accurate with 100.1% recovery and precise with %RSD-0.1 respectively. The method was found to be specific with no interference of drug from the excipients. Stress studies or forced degradation studies were carried out at different conditions like thermal, acidic, basic, photolytic, peroxide, humidity and the results revealed that the method was stable and it can be used for routine analysis in tablet dosage formulations.
Roflumilast, RP-HPLC, Method development, Validation, Stability indicating.