유전자재조합 인터페론 알파의 HPLC-PDA에 의한 함량분석

The Quantitative HPLC-PDA Method for Recombinant Interferon Alpha Analysis

Recombinant interferon alpha-2a is an active formula for the treatment of various cancer cells like malignant melanoma and a variety of virus infection diseases like acute or chronic hepatitis. The bioassay system based on the measurement of virus inhibitory activity by interferon has been used for interferon analysis with low repeatability. Here, we developed the HPLC assay to measure reproducibly interferon alpha-2a protein content which is replaceable to the reported bioassay. This method separated interferon alpha-2a from its oxidized forms and human serum albumin used as excipients. The regression coefficient using interferon alpha-2a EP CRS is more than 0.9 in the range from 5 μg/ml to 200 μg/ml. The recovery result in the range from 15 μg/ml to 60 μg/ml is 97~104% and the precision is 0.2~1.7%. The interferon alpha contents of 5 products are about 30 μg/ml.