Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1216124 | Journal of Chromatography B | 2006 | 5 Pages |
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.