Validation of a method for monitoring the manufacture of human insulin

A method for monitoring the manufacture of human insulin by HPLC was developed. The method was validated by the estimation of its linearity, accuracy, precision, specificity, and robustness; the limits of detection and quantitative assessment were also determined. It was proven that HPLC analysis en...

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Bibliographic Details
Published in:Russian journal of bioorganic chemistry 2009, Vol.35 (1), p.47-53
Main Authors: Gusarov, D. A., Gusarova, V. D., Mikhalev, A. V., Lasman, V. A., Bairamashvili, D. I., Mironov, A. F., Senatorova, N. K., Senatorov, A. V.
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedicine
Bioorganic Chemistry
Life Sciences
Organic Chemistry
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Summary:A method for monitoring the manufacture of human insulin by HPLC was developed. The method was validated by the estimation of its linearity, accuracy, precision, specificity, and robustness; the limits of detection and quantitative assessment were also determined. It was proven that HPLC analysis enables reliable and reproducible results to be obtained and can be used for monitoring insulin manufacture.
ISSN:1068-1620
1608-330X
DOI:10.1134/S1068162009010063