A simple and rapid HPLC method for quantitation of interferon-α2b in dosage forms and delivery systems

Development of reliable assay methods for quantitation of interferons in dosage forms has encountered serious limitations because of the physicochemical nature of these proteins as well as the sensitivity/selectivity issues. A rapid, available, and easy-to-use reversed-phase HPLC method has been developed for quantitative analysis of interferon-α2b in pharmaceuticals. The reversed- phase method was based on a gradient system using a wide-pore C4 column and produced linear response in drug concentration range of 0.25–5 MIU (r = 0.9997). The average within-run and between-run variables of the method were 4.19 and 9.40%, respectively, with corresponding average accuracies of 99.48 ± 4.11 and 102.83 ± 9.51%. The limits of detection (LOD) and quantitation (LOQ) of the method were 0.125 and 0.25 MIU/ml, respectively. The practical applicability of the method was proven throughout a post-marketing quality control program on interferon-α2b products (PD-feron®) produced and marketed in Iran.