Zhao H.,Anhui Biological Institute |
Li Z.-L.,Anhui Biological Institute |
Zhou L.-C.,Anhui Biological Institute |
Chu C.-F.,Anhui Biological Institute |
And 3 more authors.
Chinese Journal of Biologicals | Year: 2012
Objective: To determine the Tween 80 content in recombinant human interferon α2b injection by HPLC. Methods: Under designed condition, HPLC was verified for specificity, systemic suitability, intra- and inter-reproducibility and accuracy, and determined for linear range and minimum detection limit. The Tween 80 contents in three batches of recombinant human interferon α2b injection were determined by HPLC method. Results: The HPLC method showed good specificity, suitability and linearity (R2 = 0.999 8), of which the linear range was 0.031 25-2.5 mg/ml. In intra-reproducibility test, the RSDs of peak area and concentration were 0.71% and 0.56% respectively. In inter-reproducibility test, the RSDs of retention time and peak area were 0.47% and 2.76%respectively. The recovery rates of three batches of samples loaded were 101.99%inverted commas99.96% and 102.2% respectively, with a RSD of 1.16%. The Tween 80 contents in three batches of interferon α2b injection were 0.940inverted commas0.936 and 0.950 mg/ml, which were 94.0%inverted commas93.6% and 95.0% of stated amounts, respectively. Conclusion: HPLC method was accurate, rapid and reliable, which might be used for determination of Tween 80 content in recombinant human interferon α2b injection.