A simple and rapid HPLC method for quantitation of interferon-alpha2b in dosage forms and delivery systems

• Published in: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 833; no. 2; pp. 199 - 203
• Main Authors: Zarrin, Abdolhossein, Foroozesh, Mahshid, Hamidi, Mehrdad, Mohammadi-Samani, Soleyman
• Format: Journal Article
• Language: English
• Published: Netherlands 03.04.2006
• Subjects: Chromatography, High Pressure Liquid - methods; Dosage Forms; Interferon-alpha - analysis; Recombinant Proteins; Reference Standards; Reproducibility of Results; Sensitivity and Specificity
• ISSN: 1570-0232

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-alpha2b 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 0.25MIU/ml, respectively. The practical applicability of the method was proven throughout a post-marketing quality control program on interferon-alpha2b products (PD-feron) produced and marketed in Iran.