A simple and rapid HPLC method for quantitation of interferon-alpha2b 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-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.
Zarrin
Abdolhossein
A
Department of Pharmaceutics, Faculty of Pharmacy, Shiraz University of Medical Sciences, P.O. Box 71345-1583, Shiraz, Iran.
Foroozesh
Mahshid
M
Hamidi
Mehrdad
M
Mohammadi-Samani
Soleyman
S
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
D004304:Dosage Forms; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins