Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method
Introduction. B-cell malignancies of the plasma cell leads to the second most spread hematological malignancy disease, called multiple myeloma. Pomalidomide is used in case of previous multiple myeloma ineffective treatment. Pomalidomide is a thalidomide synthetic derived, approved as immunomodulato...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2020-11-01
|
| Series: | Разработка и регистрация лекарственных средств |
| Subjects: | |
| Online Access: | https://www.pharmjournal.ru/jour/article/view/864 |
| _version_ | 1826569723639234560 |
|---|---|
| author | T. N. Komarov I. E. Shohin M. A. Tokareva O. A. Archakova D. S. Bogdanova A. A. Aleshina N. S. Bagaeva V. V. Davydanova N. P. Sadchikova |
| author_facet | T. N. Komarov I. E. Shohin M. A. Tokareva O. A. Archakova D. S. Bogdanova A. A. Aleshina N. S. Bagaeva V. V. Davydanova N. P. Sadchikova |
| author_sort | T. N. Komarov |
| collection | DOAJ |
| description | Introduction. B-cell malignancies of the plasma cell leads to the second most spread hematological malignancy disease, called multiple myeloma. Pomalidomide is used in case of previous multiple myeloma ineffective treatment. Pomalidomide is a thalidomide synthetic derived, approved as immunomodulatory drug by the Food and Drug Administration (FDA). Nowadays, detection of pomalidomide in blood plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) is not spread. Moreover, the detection and the experimental setting accumulated data are varying greatly. This investigation provides development and validation of pomalidomide aiming to determine human blood plasma by HPLC-MS/MS method. The samples were processed by methanol protein precipitation.Aim. The aim of this study is to develop a method for the pomalidomide in human plasma by HPLC-MS/MS for pharmacokinetic studies.Materials and methods. Determination of pomalidomide in plasma by HPLC-MS/MS. The samples were processed by methanol protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, lower limit of quantification, detection limit, carry-over and stability.Conclusion. The method of the determination of pomalidomide in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 1,00 – 500,00 ng/ml. Method could be applied to pomalidomide determination in plasma for PK and BE studies. |
| first_indexed | 2024-04-10T01:39:48Z |
| format | Article |
| id | doaj.art-060330515ca5438280d1365ce58a2396 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2025-03-14T11:43:52Z |
| publishDate | 2020-11-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-060330515ca5438280d1365ce58a23962025-03-02T09:53:24ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492020-11-019414615410.33380/2305-2066-2020-9-4-146-154792Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS MethodT. N. Komarov0I. E. Shohin1M. A. Tokareva2O. A. Archakova3D. S. Bogdanova4A. A. Aleshina5N. S. Bagaeva6V. V. Davydanova7N. P. Sadchikova8LLC «CPHA»LLC «CPHA»I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)LLC «CPHA»LLC «CPHA»LLC «CPHA»LLC «CPHA»LLC «CPHA»I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)Introduction. B-cell malignancies of the plasma cell leads to the second most spread hematological malignancy disease, called multiple myeloma. Pomalidomide is used in case of previous multiple myeloma ineffective treatment. Pomalidomide is a thalidomide synthetic derived, approved as immunomodulatory drug by the Food and Drug Administration (FDA). Nowadays, detection of pomalidomide in blood plasma by high performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS) is not spread. Moreover, the detection and the experimental setting accumulated data are varying greatly. This investigation provides development and validation of pomalidomide aiming to determine human blood plasma by HPLC-MS/MS method. The samples were processed by methanol protein precipitation.Aim. The aim of this study is to develop a method for the pomalidomide in human plasma by HPLC-MS/MS for pharmacokinetic studies.Materials and methods. Determination of pomalidomide in plasma by HPLC-MS/MS. The samples were processed by methanol protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, spike recovery, lower limit of quantification, detection limit, carry-over and stability.Conclusion. The method of the determination of pomalidomide in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 1,00 – 500,00 ng/ml. Method could be applied to pomalidomide determination in plasma for PK and BE studies.https://www.pharmjournal.ru/jour/article/view/864pomalidomideplasmahplc-ms/msvalidationbioequivalence |
| spellingShingle | T. N. Komarov I. E. Shohin M. A. Tokareva O. A. Archakova D. S. Bogdanova A. A. Aleshina N. S. Bagaeva V. V. Davydanova N. P. Sadchikova Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method Разработка и регистрация лекарственных средств pomalidomide plasma hplc-ms/ms validation bioequivalence |
| title | Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method |
| title_full | Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method |
| title_fullStr | Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method |
| title_full_unstemmed | Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method |
| title_short | Development and Validation of Pomalidomide Determination in Human Plasma by HPLC-MS/MS Method |
| title_sort | development and validation of pomalidomide determination in human plasma by hplc ms ms method |
| topic | pomalidomide plasma hplc-ms/ms validation bioequivalence |
| url | https://www.pharmjournal.ru/jour/article/view/864 |
| work_keys_str_mv | AT tnkomarov developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT ieshohin developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT matokareva developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT oaarchakova developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT dsbogdanova developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT aaaleshina developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT nsbagaeva developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT vvdavydanova developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod AT npsadchikova developmentandvalidationofpomalidomidedeterminationinhumanplasmabyhplcmsmsmethod |