Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation
Impurities compounds in any pharmaceutical product or drug substance are inevitable from a chemistry point of view. The quality and safety of a pharmaceutical product are also significantly affected by these impurities content; therefore, impurities need to be identified and characterized through th...
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| Format: | Article |
| Language: | English |
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Wiley
2024-01-01
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| Series: | Advances in Pharmacological and Pharmaceutical Sciences |
| Online Access: | http://dx.doi.org/10.1155/2024/5583526 |
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| author | Raymond R. Tjandrawinata Antonius H. Cahyana Ajeng O. Nugroho Indra K. Adi Joseph S. R. Talpaneni |
| author_facet | Raymond R. Tjandrawinata Antonius H. Cahyana Ajeng O. Nugroho Indra K. Adi Joseph S. R. Talpaneni |
| author_sort | Raymond R. Tjandrawinata |
| collection | DOAJ |
| description | Impurities compounds in any pharmaceutical product or drug substance are inevitable from a chemistry point of view. The quality and safety of a pharmaceutical product are also significantly affected by these impurities content; therefore, impurities need to be identified and characterized through the use of appropriate analytical methods. Pramipexole is a nonergot dopamine agonist used to treat various Parkinson’s disease symptoms. Two unknown impurities were detected from a pramipexole dihydrochloride solid dosage form. These impurities were identified and characterized using ultra-performance liquid chromatography coupled with high-resolution mass spectroscopy (UPLC-HRMS). These impurities were found to be enriched when mannitol existed in the formulation. The structure and mechanism involved in the existence of the impurities were proposed. Furthermore, observation of the binding affinity potential risk of these impurities to the pramipexole receptor has also been demonstrated through molecular docking and molecular dynamics simulation study. The binding energy result showed that pramipexole interaction with dopamine receptors D2 and D3 was higher than pramipexole mannose adduct and pramipexole ribose adduct. |
| format | Article |
| id | doaj-art-482e765e0817401d8063417db71ad300 |
| institution | Kabale University |
| issn | 2633-4690 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Advances in Pharmacological and Pharmaceutical Sciences |
| spelling | doaj-art-482e765e0817401d8063417db71ad3002025-02-03T05:57:03ZengWileyAdvances in Pharmacological and Pharmaceutical Sciences2633-46902024-01-01202410.1155/2024/5583526Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug FormulationRaymond R. Tjandrawinata0Antonius H. Cahyana1Ajeng O. Nugroho2Indra K. Adi3Joseph S. R. Talpaneni4Atma Jaya Catholic University of IndonesiaDepartment of ChemistryDepartment of ChemistryDexa Development CentreDexa Development CentreImpurities compounds in any pharmaceutical product or drug substance are inevitable from a chemistry point of view. The quality and safety of a pharmaceutical product are also significantly affected by these impurities content; therefore, impurities need to be identified and characterized through the use of appropriate analytical methods. Pramipexole is a nonergot dopamine agonist used to treat various Parkinson’s disease symptoms. Two unknown impurities were detected from a pramipexole dihydrochloride solid dosage form. These impurities were identified and characterized using ultra-performance liquid chromatography coupled with high-resolution mass spectroscopy (UPLC-HRMS). These impurities were found to be enriched when mannitol existed in the formulation. The structure and mechanism involved in the existence of the impurities were proposed. Furthermore, observation of the binding affinity potential risk of these impurities to the pramipexole receptor has also been demonstrated through molecular docking and molecular dynamics simulation study. The binding energy result showed that pramipexole interaction with dopamine receptors D2 and D3 was higher than pramipexole mannose adduct and pramipexole ribose adduct.http://dx.doi.org/10.1155/2024/5583526 |
| spellingShingle | Raymond R. Tjandrawinata Antonius H. Cahyana Ajeng O. Nugroho Indra K. Adi Joseph S. R. Talpaneni Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation Advances in Pharmacological and Pharmaceutical Sciences |
| title | Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation |
| title_full | Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation |
| title_fullStr | Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation |
| title_full_unstemmed | Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation |
| title_short | Structure Identification and Risk Assurance of Unknown Impurities in Pramipexole Oral Drug Formulation |
| title_sort | structure identification and risk assurance of unknown impurities in pramipexole oral drug formulation |
| url | http://dx.doi.org/10.1155/2024/5583526 |
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