title: A simple and rapid HPLC method for quantitation of interferon-alpha2b in dosage forms and delivery systems.
abstract: 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.
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Shiraz University of Medical Sciences, P.O. Box 71345-1583, Shiraz, Iran.
authors.forename: Abdolhossein
authors.initials: A
authors.lastname: Zarrin
authors.forename: Mahshid
authors.initials: M
authors.lastname: Foroozesh
authors.forename: Mehrdad
authors.initials: M
authors.lastname: Hamidi
authors.forename: Soleyman
authors.initials: S
authors.lastname: Mohammadi-Samani
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000032:analysis*; D011994:Recombinant Proteins; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004304:Dosage Forms; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins