Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study
Copanlisib is a pan phosphatidylinositol 3-kinase (PI3K) inhibitor approved for follicular lymphoma. In this paper, we present the data of development and validation of a high-performance liquid chromatography (HPLC) method for the quantitation of copanlisib in mice plasma as per the FDA regulatory...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
International Association of Physical Chemists (IAPC)
2020-03-01
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| Series: | ADMET and DMPK |
| Subjects: | |
| Online Access: | http://pub.iapchem.org/ojs/index.php/admet/article/view/782 |
| _version_ | 1828860759391600640 |
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| author | Ashok Zakkula Pavan Kumar Kurakula Sreekanth Dittakavi Prasanthi Daram Ram Murthi Bestha Mohd Zainuddin Ravi Kumar Trivedi Ramesh Mullangi |
| author_facet | Ashok Zakkula Pavan Kumar Kurakula Sreekanth Dittakavi Prasanthi Daram Ram Murthi Bestha Mohd Zainuddin Ravi Kumar Trivedi Ramesh Mullangi |
| author_sort | Ashok Zakkula |
| collection | DOAJ |
| description | Copanlisib is a pan phosphatidylinositol 3-kinase (PI3K) inhibitor approved for follicular lymphoma. In this paper, we present the data of development and validation of a high-performance liquid chromatography (HPLC) method for the quantitation of copanlisib in mice plasma as per the FDA regulatory guideline. The method involves the extraction of copanlisib along with internal standard (IS, enasidenib) from mice plasma (100 µL) using ethyl acetate as an extraction solvent. The chromatographic resolution of copanlisib and the IS was achieved on a Hypersil Gold C18 column maintained at 40 °C using a binary gradient mobile phase [10 mM ammonium formate (pH 4.0) and acetonitrile]. The flow-rate was 0.8 mL/min. For the detection of copanlisib and the IS, the photo-diode array detector was set at λmax 310 nm. Copanlisib and the IS eluted at 6.60 and 7.80 min, respectively with a total run time of 10 min. The calibration curve was linear over a concentration range of 50 to 5000 ng/mL for copanlisib (r2³ 0.998). The results of intra- and inter-day accuracy and precision studies were within the acceptable limits. Copanlisib was stable on bench-top, in auto-sampler, up to three freeze/thaw cycle and long-term storage at -80 °C. The application of the validated method was shown in a mice pharmacokinetic study. |
| first_indexed | 2024-12-13T02:46:40Z |
| format | Article |
| id | doaj.art-4df85a94e3de48d495394a05befcbc07 |
| institution | Directory Open Access Journal |
| issn | 1848-7718 |
| language | English |
| last_indexed | 2024-12-13T02:46:40Z |
| publishDate | 2020-03-01 |
| publisher | International Association of Physical Chemists (IAPC) |
| record_format | Article |
| series | ADMET and DMPK |
| spelling | doaj.art-4df85a94e3de48d495394a05befcbc072022-12-22T00:02:10ZengInternational Association of Physical Chemists (IAPC)ADMET and DMPK1848-77182020-03-018111312110.5599/admet.782419Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic studyAshok ZakkulaPavan Kumar KurakulaSreekanth DittakaviPrasanthi DaramRam Murthi BesthaMohd ZainuddinRavi Kumar TrivediRamesh MullangiCopanlisib is a pan phosphatidylinositol 3-kinase (PI3K) inhibitor approved for follicular lymphoma. In this paper, we present the data of development and validation of a high-performance liquid chromatography (HPLC) method for the quantitation of copanlisib in mice plasma as per the FDA regulatory guideline. The method involves the extraction of copanlisib along with internal standard (IS, enasidenib) from mice plasma (100 µL) using ethyl acetate as an extraction solvent. The chromatographic resolution of copanlisib and the IS was achieved on a Hypersil Gold C18 column maintained at 40 °C using a binary gradient mobile phase [10 mM ammonium formate (pH 4.0) and acetonitrile]. The flow-rate was 0.8 mL/min. For the detection of copanlisib and the IS, the photo-diode array detector was set at λmax 310 nm. Copanlisib and the IS eluted at 6.60 and 7.80 min, respectively with a total run time of 10 min. The calibration curve was linear over a concentration range of 50 to 5000 ng/mL for copanlisib (r2³ 0.998). The results of intra- and inter-day accuracy and precision studies were within the acceptable limits. Copanlisib was stable on bench-top, in auto-sampler, up to three freeze/thaw cycle and long-term storage at -80 °C. The application of the validated method was shown in a mice pharmacokinetic study.http://pub.iapchem.org/ojs/index.php/admet/article/view/782copanlisibhplcmethod validationmice plasmapharmacokinetics |
| spellingShingle | Ashok Zakkula Pavan Kumar Kurakula Sreekanth Dittakavi Prasanthi Daram Ram Murthi Bestha Mohd Zainuddin Ravi Kumar Trivedi Ramesh Mullangi Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study ADMET and DMPK copanlisib hplc method validation mice plasma pharmacokinetics |
| title | Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study |
| title_full | Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study |
| title_fullStr | Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study |
| title_full_unstemmed | Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study |
| title_short | Validated HPLC method for quantification of copanlisib in mice plasma: application to a pharmacokinetic study |
| title_sort | validated hplc method for quantification of copanlisib in mice plasma application to a pharmacokinetic study |
| topic | copanlisib hplc method validation mice plasma pharmacokinetics |
| url | http://pub.iapchem.org/ojs/index.php/admet/article/view/782 |
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