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Development and Validation of a Micellar Capillary Electrophoresis Method for Determination of Ifnβ-1B in Lyophilized Formulation of a Biosimilar Product



Dadgarnejad M1 ; Rastegar H1 ; Ilka H3 ; Shekarchi M1 ; Adib N1 ; Alebouyeh M1 ; Keypour N1 ; Shoeibi S1 ; Kobarfard F4 ; Fazeli MR2
Authors
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Authors Affiliations
  1. 1. Center of Food and Drug Control References Laboratories (CFDCRL), Food and Drug Organization (FDO), Ministry of Health and Medical Education (MOH), Tehran, Iran
  2. 2. Department of Drug and Food Control, Pharmaceutical Quality Assurance Research Center, Tehran University of Medical Sciences (TUMS), Tehran, Iran
  3. 3. Research and Development Department, Zistdaru Danesh Co. Ltd, No. 1462, North Kargar Street, Tehran, Iran
  4. 4. Department of Medicinal Chemistry, School of Pharmacy, Phytochemistry Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Source: Iranian Journal of Pharmaceutical Research Published:2015

Abstract

Human interferons (IFNs) are key cytokines secreted by immune system. They have several effects such as antiviral and anti tumors activity, activating immune cells and healing of multiple sclerosis. The type IFNs present in humans are α ,β and Υ. IFN β is a polypeptide, normally produced by fibroblasts and seems to be more species-specific than IFN. Structural properties of IFNs are important for their biologic effects. There are a few analytical techniques for separation, identification and determination of IFNs in its formulations such as mass spectroscopy, RP-HPLC and capillary electrophoresis (CE). In this study we used Micellar Electrokinetic Chromatography (MEKC) as a unique mode of CE because of its capability to separate neutral as well as charged solutes. We used sodium tetraborate (Borax) as buffer without any modifier and sodium dodecyl sulfate (SDS) as surfactant. The optimum MECK running buffer consisted of Borate 50 Mm; SDS 20 mM pH =9.6. The validated method was used for determination of the IFN β-1b formulation which is manufactured in Iran. From 9 collected different batches, all of them had acceptable potency as claimed on their label with average 102.25 ±10.030 %. This is the first time that a MEKC method is introduced for quantification of IFN β-1b in its pharmaceutical dosage forms. The method is reliable safe, rapid and accurate. © 2015 by School of Pharmacy Shaheed Beheshti University of Medical Sciences and Health Services.