DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS
Method of determination of polysorbate 20 and polysorbate 80 in recombinant protein drugs based on spectrophotometry has been designed. Isolation of polysorbate from solution is carried out by solid phase extraction followed by elution of polysorbate with acetonitrile. Acetonitrile solution is evapo...
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2019-01-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/469 |
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| author | A. D. Askretkov P. M. Isaykina S. A. Cherepushkin N. V. Orlova |
| author_facet | A. D. Askretkov P. M. Isaykina S. A. Cherepushkin N. V. Orlova |
| author_sort | A. D. Askretkov |
| collection | DOAJ |
| description | Method of determination of polysorbate 20 and polysorbate 80 in recombinant protein drugs based on spectrophotometry has been designed. Isolation of polysorbate from solution is carried out by solid phase extraction followed by elution of polysorbate with acetonitrile. Acetonitrile solution is evaporated and then polysorbate is derivatized with ferrous-thiocyanate reagent. Obtained derivative is extracted into organic phase and optical density is measured. The most optimal conditions of derivatization, extraction into organic phase and measurment was chosen. The validation was performed: specificity, linearity, accuracy, precision, robustness, limit of quantification. |
| format | Article |
| id | doaj-art-841b8c3eb6fc4e55bb23675a9958b18f |
| institution | Kabale University |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| publishDate | 2019-01-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj-art-841b8c3eb6fc4e55bb23675a9958b18f2025-08-20T03:59:20ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492019-01-0103124129469DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINSA. D. Askretkov0P. M. Isaykina1S. A. Cherepushkin2N. V. Orlova3Moscow Technological University (MITHT)Moscow Technological University (MITHT)Scientific Center of Russian Federation «Research Institute for Genetics and Selection of Industrial Microorganisms»Scientific Center of Russian Federation «Research Institute for Genetics and Selection of Industrial Microorganisms»Method of determination of polysorbate 20 and polysorbate 80 in recombinant protein drugs based on spectrophotometry has been designed. Isolation of polysorbate from solution is carried out by solid phase extraction followed by elution of polysorbate with acetonitrile. Acetonitrile solution is evaporated and then polysorbate is derivatized with ferrous-thiocyanate reagent. Obtained derivative is extracted into organic phase and optical density is measured. The most optimal conditions of derivatization, extraction into organic phase and measurment was chosen. The validation was performed: specificity, linearity, accuracy, precision, robustness, limit of quantification.https://www.pharmjournal.ru/jour/article/view/469validationrecombinant proteinspolysorbatesolid phase extractiontweeniron thiocyanate |
| spellingShingle | A. D. Askretkov P. M. Isaykina S. A. Cherepushkin N. V. Orlova DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS Разработка и регистрация лекарственных средств validation recombinant proteins polysorbate solid phase extraction tween iron thiocyanate |
| title | DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS |
| title_full | DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS |
| title_fullStr | DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS |
| title_full_unstemmed | DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS |
| title_short | DETERMINATION OF POLYSORBATES BY SPECTROPHOTOMETRY IN DRUGS BASED ON RECOMBINANT PROTEINS |
| title_sort | determination of polysorbates by spectrophotometry in drugs based on recombinant proteins |
| topic | validation recombinant proteins polysorbate solid phase extraction tween iron thiocyanate |
| url | https://www.pharmjournal.ru/jour/article/view/469 |
| work_keys_str_mv | AT adaskretkov determinationofpolysorbatesbyspectrophotometryindrugsbasedonrecombinantproteins AT pmisaykina determinationofpolysorbatesbyspectrophotometryindrugsbasedonrecombinantproteins AT sacherepushkin determinationofpolysorbatesbyspectrophotometryindrugsbasedonrecombinantproteins AT nvorlova determinationofpolysorbatesbyspectrophotometryindrugsbasedonrecombinantproteins |