Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach
Objectives. We hereby describe an improvement of a previously developed quantification technique for polysorbate 80 in biopharmaceutical formulations (darbepoetin alfa and eculizumab) and report the validation of the new approach.Methods. Polysorbate was isolated from analyte samples by protein prec...
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| Format: | Article |
| Language: | Russian |
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MIREA - Russian Technological University
2020-07-01
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| Series: | Тонкие химические технологии |
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| Online Access: | https://www.finechem-mirea.ru/jour/article/view/1625 |
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| author | A. S. Seregin N. V. Orlova A. D. Askretkov D. I. Zybin Yu. A. Seregin |
| author_facet | A. S. Seregin N. V. Orlova A. D. Askretkov D. I. Zybin Yu. A. Seregin |
| author_sort | A. S. Seregin |
| collection | DOAJ |
| description | Objectives. We hereby describe an improvement of a previously developed quantification technique for polysorbate 80 in biopharmaceutical formulations (darbepoetin alfa and eculizumab) and report the validation of the new approach.Methods. Polysorbate was isolated from analyte samples by protein precipitation using an organic solvent, followed by supernatant evaporation in vacuum. Polysorbate was derivatized using a ferric thiocyanate reagent and extracted into an organic phase; the relevant optical density measurements were performed.Results. We established the optimal conditions for each step of the analysis procedure. The accuracy was 97–102% in the tested analytical range, the relative standard deviation did not exceed 5%, and the limit of quantification was 0.01 mg/mL.Conclusions. The reported approach is highly sensitive; polysorbate isolation and quantification do not depend on the matrix or, most importantly, the protein. |
| format | Article |
| id | doaj-art-c06d532a15bc476a8561ddd4150b6092 |
| institution | DOAJ |
| issn | 2410-6593 2686-7575 |
| language | Russian |
| publishDate | 2020-07-01 |
| publisher | MIREA - Russian Technological University |
| record_format | Article |
| series | Тонкие химические технологии |
| spelling | doaj-art-c06d532a15bc476a8561ddd4150b60922025-08-20T03:23:07ZrusMIREA - Russian Technological UniversityТонкие химические технологии2410-65932686-75752020-07-01153707710.32362/2410-6593-2020-15-3-70-771596Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approachA. S. Seregin0N. V. Orlova1A. D. Askretkov2D. I. Zybin3Yu. A. Seregin4Scientific Center “Kurchatov Institute,” Research Institute for Genetics and Selection of Industrial MicroorganismsScientific Center “Kurchatov Institute,” Research Institute for Genetics and Selection of Industrial MicroorganismsPHARMAPARKPHARMAPARKScientific Center “Kurchatov Institute,” Research Institute for Genetics and Selection of Industrial MicroorganismsObjectives. We hereby describe an improvement of a previously developed quantification technique for polysorbate 80 in biopharmaceutical formulations (darbepoetin alfa and eculizumab) and report the validation of the new approach.Methods. Polysorbate was isolated from analyte samples by protein precipitation using an organic solvent, followed by supernatant evaporation in vacuum. Polysorbate was derivatized using a ferric thiocyanate reagent and extracted into an organic phase; the relevant optical density measurements were performed.Results. We established the optimal conditions for each step of the analysis procedure. The accuracy was 97–102% in the tested analytical range, the relative standard deviation did not exceed 5%, and the limit of quantification was 0.01 mg/mL.Conclusions. The reported approach is highly sensitive; polysorbate isolation and quantification do not depend on the matrix or, most importantly, the protein.https://www.finechem-mirea.ru/jour/article/view/1625validationdarbepoetin alfaeculizumabpolysorbateprecipitationferric thiocyanate |
| spellingShingle | A. S. Seregin N. V. Orlova A. D. Askretkov D. I. Zybin Yu. A. Seregin Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach Тонкие химические технологии validation darbepoetin alfa eculizumab polysorbate precipitation ferric thiocyanate |
| title | Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach |
| title_full | Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach |
| title_fullStr | Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach |
| title_full_unstemmed | Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach |
| title_short | Quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach |
| title_sort | quantification of polysorbate 80 in biopharmaceutical formulations implementing an optimized colorimetric approach |
| topic | validation darbepoetin alfa eculizumab polysorbate precipitation ferric thiocyanate |
| url | https://www.finechem-mirea.ru/jour/article/view/1625 |
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