Development and validation of a stability indicating UPLC assay method for determination of Leflunomide in tablet formulation

reversed-phase stability indicating Ultra Performance Liquid Chromatography (UPLC) assay method and validated for determination of Leflunomide in solid pharmaceutical dosage forms. Isocratic RP-UPLC separation was achieved on a Water Acquity BEH C18, 2.4 x 50mm, 1.7μ column. The mobile phase was consisted of acetonitrile and 0.02M ammonium acetate buffer (60:40, v/v). at a flow rate of 0.4 ml/min and the detection was carried out at 260 nm by using photo-diode array detector. The flow rate of the mobile phase was adjusted to 0.4 mL/min and the injection volume was 5 μl. The drug was subjected to oxidation, hydrolysis, photolysis and heat to apply stress condition. The method was validated for specificity, linearity, precision, accuracy, robustness and solution stability. The method was linear in the drug concentration range of 10-30 μg/ml with a correlation coefficient 0.9998. The precision Relative standard deviation (RSD) amongst six-sample preparation was 1.16 % for repeatability and the intermediate precision (RSD) amongst six-sample preparation was 0.60 %. The accuracy (recovery) was between 99.44 and 100.24 %. Degradation products produced as a result of stress studies did not interfere with detection of Leflunomide and the assay can thus be considered stability indicating

Author(s): Govind J. Khera, Vijay R. Ramb , Gaurang P. Pandyaa; and Hitendra S. Joshia

Abstract | PDF

Share This Article