Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method
Abstract Background A receptive and easily comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by UPLC–MS/MS. Results This technique involves chromatographic separation with a C18 column of water symmetry (150 mm × 4.6 mm, 3...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2021-12-01
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| Series: | Future Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s43094-021-00381-6 |
| _version_ | 1819042973912924160 |
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| author | Anuradha Vejendla Subrahmanyam Talari G. Ramu Ch Rajani |
| author_facet | Anuradha Vejendla Subrahmanyam Talari G. Ramu Ch Rajani |
| author_sort | Anuradha Vejendla |
| collection | DOAJ |
| description | Abstract Background A receptive and easily comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by UPLC–MS/MS. Results This technique involves chromatographic separation with a C18 column of water symmetry (150 mm × 4.6 mm, 3.5 µm). A mobile phase of 0.1% OPA (orthophosphoric acid) and acetonitrile in 50:50 v/v with 1 mL/min flow rate and ambient temperature was used. UV observation was taken at 230 nm. The recoveries, linearity, and quantification limits were found to be within the acceptable limit. Conclusions This technique was successfully tested with UPLC–MS to confirm the chemical structures of newly formed degradation products of Bempedoic acid and Ezetimibe and stress studies as per ICH Q2 (R1) guidelines. |
| first_indexed | 2024-12-21T09:49:24Z |
| format | Article |
| id | doaj.art-c0fb128f67e44466bc68c12c3ca6d36f |
| institution | Directory Open Access Journal |
| issn | 2314-7253 |
| language | English |
| last_indexed | 2024-12-21T09:49:24Z |
| publishDate | 2021-12-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | Future Journal of Pharmaceutical Sciences |
| spelling | doaj.art-c0fb128f67e44466bc68c12c3ca6d36f2022-12-21T19:08:13ZengSpringerOpenFuture Journal of Pharmaceutical Sciences2314-72532021-12-017111310.1186/s43094-021-00381-6Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC methodAnuradha Vejendla0Subrahmanyam Talari1G. Ramu2Ch Rajani3Department of Chemistry, Vignan Degree CollegeDepartment of Chemistry, Acharya Nagarjuna UniversityDepartment of Chemistry, Sir C R Reddy CollegeDepartment of Chemistry, Vignan’s NIRULA Institute of Technology & ScienceAbstract Background A receptive and easily comprehended technique was evolved for simultaneous assessment of Bempedoic acid and Ezetimibe and its impurities characterized by UPLC–MS/MS. Results This technique involves chromatographic separation with a C18 column of water symmetry (150 mm × 4.6 mm, 3.5 µm). A mobile phase of 0.1% OPA (orthophosphoric acid) and acetonitrile in 50:50 v/v with 1 mL/min flow rate and ambient temperature was used. UV observation was taken at 230 nm. The recoveries, linearity, and quantification limits were found to be within the acceptable limit. Conclusions This technique was successfully tested with UPLC–MS to confirm the chemical structures of newly formed degradation products of Bempedoic acid and Ezetimibe and stress studies as per ICH Q2 (R1) guidelines.https://doi.org/10.1186/s43094-021-00381-6Bempedoic acidEzetimibeValidationCharacterizationUPLCUPLC–MS |
| spellingShingle | Anuradha Vejendla Subrahmanyam Talari G. Ramu Ch Rajani Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method Future Journal of Pharmaceutical Sciences Bempedoic acid Ezetimibe Validation Characterization UPLC UPLC–MS |
| title | Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method |
| title_full | Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method |
| title_fullStr | Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method |
| title_full_unstemmed | Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method |
| title_short | Characterization of novel stress degradation products of Bempedoic acid and Ezetimibe using UPLC–MS/MS: development and validation of stability-indicating UPLC method |
| title_sort | characterization of novel stress degradation products of bempedoic acid and ezetimibe using uplc ms ms development and validation of stability indicating uplc method |
| topic | Bempedoic acid Ezetimibe Validation Characterization UPLC UPLC–MS |
| url | https://doi.org/10.1186/s43094-021-00381-6 |
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