Validation of a stability-indicating LC method for assay of leflunomide in tablets and for determination of content uniformity

Abstract

A simple, precise, and accurate HPLC method has been developed and validated for assay of leflunomide in tablets and for determination of content uniformity. Reversed-phase liquid chromatographic separation was achieved by use of ammonium acetate (0.02M)-acetonitrile 40:60(v/v) as mobile phase. The method was validated for specificity, linearity, precision, accuracy, robustness, and by stress testing of the drug(forced degradation). Response was a linear function of drug concentration in the range 8-32 μg/mL (r= 0.9985). Intraday and interday system and method precision were determined. Accuracy was between 99.58 and 100.17%. The method was found to be robust, and was suitable for assay of leflunomide in a tablet formulation and for determination of content uniformity.