Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method
Introduction. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatograp...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | Russian |
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LLC Center of Pharmaceutical Analytics (LLC «CPHA»)
2021-02-01
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| Series: | Разработка и регистрация лекарственных средств |
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| Online Access: | https://www.pharmjournal.ru/jour/article/view/898 |
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| author | T. N. Komarov I. E. Shohin M. A. Tokareva O. A. Archakova D. S. Bogdanova A. V. Aleshina N. S. Bagaeva V. V. Davydanova |
| author_facet | T. N. Komarov I. E. Shohin M. A. Tokareva O. A. Archakova D. S. Bogdanova A. V. Aleshina N. S. Bagaeva V. V. Davydanova |
| author_sort | T. N. Komarov |
| collection | DOAJ |
| description | Introduction. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatographic separation of so-called poorly retained compounds – drug substances poorly retained on the chromatographic column. Valganciclovir and Ganciclovir are among such substances.Aim. The aim of this study is to develop a method for valganciclovir and ganciclovir in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.Materials and methods. Determination of valganciclovir and ganciclovir in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over and stability.Conclusion. The method of the determination of valganciclovir and ganciclovir in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 5.00–1000.00 ng/ml for valganciclovir and 50.00–10000.00 ng/ml for ganciclovir. Method could be applied to valganciclovir and ganciclovir determination in plasma for PK and BE studies. |
| first_indexed | 2024-04-10T01:39:22Z |
| format | Article |
| id | doaj.art-96c90649dd0d4b6b90188d21a4eff558 |
| institution | Directory Open Access Journal |
| issn | 2305-2066 2658-5049 |
| language | Russian |
| last_indexed | 2025-03-14T11:44:30Z |
| publishDate | 2021-02-01 |
| publisher | LLC Center of Pharmaceutical Analytics (LLC «CPHA») |
| record_format | Article |
| series | Разработка и регистрация лекарственных средств |
| spelling | doaj.art-96c90649dd0d4b6b90188d21a4eff5582025-03-02T09:53:24ZrusLLC Center of Pharmaceutical Analytics (LLC «CPHA»)Разработка и регистрация лекарственных средств2305-20662658-50492021-02-0110112012810.33380/2305-2066-2021-10-1-120-128810Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS MethodT. N. Komarov0I. E. Shohin1M. A. Tokareva2O. A. Archakova3D. S. Bogdanova4A. V. Aleshina5N. S. Bagaeva6V. V. Davydanova7LLC «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»Introduction. Currently, physicochemical methods of quantification are actively used to determine the content of drugs in biological fluids. High-performance liquid chromatography with various detection methods is particularly widespread. One of the most difficult practical tasks is the chromatographic separation of so-called poorly retained compounds – drug substances poorly retained on the chromatographic column. Valganciclovir and Ganciclovir are among such substances.Aim. The aim of this study is to develop a method for valganciclovir and ganciclovir in human plasma by high performance liquid chromatography with tandem mass-spectrometry (HPLC-MS/MS) for pharmacokinetic studies.Materials and methods. Determination of valganciclovir and ganciclovir in plasma by HPLC-MS/MS. The samples were processed by acetonitrile protein precipitation.Results and discussion. This method was validated by next parameters: selectivity, matrix effect, calibration curve, accuracy, precision, recovery, lower limit of quantification, carry-over and stability.Conclusion. The method of the determination of valganciclovir and ganciclovir in human plasma was developed and validated by HPLC-MS/MS. The linearity in plasma sample was achieved in the concentration range of 5.00–1000.00 ng/ml for valganciclovir and 50.00–10000.00 ng/ml for ganciclovir. Method could be applied to valganciclovir and ganciclovir determination in plasma for PK and BE studies.https://www.pharmjournal.ru/jour/article/view/898valganciclovirganciclovirplasmahplc-ms/msvalidationbioequivalence |
| spellingShingle | T. N. Komarov I. E. Shohin M. A. Tokareva O. A. Archakova D. S. Bogdanova A. V. Aleshina N. S. Bagaeva V. V. Davydanova Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method Разработка и регистрация лекарственных средств valganciclovir ganciclovir plasma hplc-ms/ms validation bioequivalence |
| title | Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method |
| title_full | Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method |
| title_fullStr | Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method |
| title_full_unstemmed | Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method |
| title_short | Development and Validation of Valganciclovir and its Active Metabolite Ganciclovir Determination in Human Plasma by HPLC-MS/MS Method |
| title_sort | development and validation of valganciclovir and its active metabolite ganciclovir determination in human plasma by hplc ms ms method |
| topic | valganciclovir ganciclovir plasma hplc-ms/ms validation bioequivalence |
| url | https://www.pharmjournal.ru/jour/article/view/898 |
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