Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products
The goal of this study was the optimization of chromatographic conditions and validation of the isocratic RP-HPLC method for monitoring the stability of aripiprazole, identification and quantitative analysis of aripiprazole and its degradation products in tablets. In addition, robustness was tested...
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| Format: | Article |
| Language: | srp |
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Pharmaceutical Association of Serbia, Belgrade, Serbia
2023-01-01
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| Series: | Arhiv za farmaciju |
| Subjects: | |
| Online Access: | https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2023/0004-19632303216M.pdf |
| _version_ | 1797743729883217920 |
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| author | Mijatović Vesna Zečević Mira Zirojević Jelena |
| author_facet | Mijatović Vesna Zečević Mira Zirojević Jelena |
| author_sort | Mijatović Vesna |
| collection | DOAJ |
| description | The goal of this study was the optimization of chromatographic conditions and validation of the isocratic RP-HPLC method for monitoring the stability of aripiprazole, identification and quantitative analysis of aripiprazole and its degradation products in tablets. In addition, robustness was tested by applying the methodology of experimental design. The forced degradation study of aripiprazole was conducted in accordance with the ICH guidelines. The stability of the active pharmaceutical substance was tested under the conditions of hydrolysis in acidic, neutral and basic environments, thermal degradation, oxidation and photolysis. The active pharmaceutical ingredient was degraded under oxidation conditions, and the identity of the resulting degradation product, N-oxide, was confirmed. Under the other conditions tested, the active pharmaceutical substance was found to be stable. The developed method RP-HPLC allowed the separation of degradation products and aripiprazole and was defined as a stability-indicating method. The proposed method was validated for qualitative and quantitative analysis of aripiprazole and its degradation products. Accordingly, selectivity, linearity, precision, accuracy, limit of detection, limit of quantification, and robustness of the method were tested. The Box-Behnken experimental design was used in robustness testing. |
| first_indexed | 2024-03-12T14:59:37Z |
| format | Article |
| id | doaj.art-87e4c915397f4ace9f82899a5ca92748 |
| institution | Directory Open Access Journal |
| issn | 0004-1963 2217-8767 |
| language | srp |
| last_indexed | 2024-03-12T14:59:37Z |
| publishDate | 2023-01-01 |
| publisher | Pharmaceutical Association of Serbia, Belgrade, Serbia |
| record_format | Article |
| series | Arhiv za farmaciju |
| spelling | doaj.art-87e4c915397f4ace9f82899a5ca927482023-08-14T09:07:41ZsrpPharmaceutical Association of Serbia, Belgrade, SerbiaArhiv za farmaciju0004-19632217-87672023-01-017332162350004-19632303216MDevelopment and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation productsMijatović Vesna0Zečević Mira1https://orcid.org/0000-0003-1531-2501Zirojević Jelena2Medicines and Medical Devices Agency of Serbia, Belgrade, SerbiaUniversity of Belgrade, Faculty of Pharmacy, Department of Drug Analysis, Belgrade, SerbiaMedicines and Medical Devices Agency of Serbia, Belgrade, SerbiaThe goal of this study was the optimization of chromatographic conditions and validation of the isocratic RP-HPLC method for monitoring the stability of aripiprazole, identification and quantitative analysis of aripiprazole and its degradation products in tablets. In addition, robustness was tested by applying the methodology of experimental design. The forced degradation study of aripiprazole was conducted in accordance with the ICH guidelines. The stability of the active pharmaceutical substance was tested under the conditions of hydrolysis in acidic, neutral and basic environments, thermal degradation, oxidation and photolysis. The active pharmaceutical ingredient was degraded under oxidation conditions, and the identity of the resulting degradation product, N-oxide, was confirmed. Under the other conditions tested, the active pharmaceutical substance was found to be stable. The developed method RP-HPLC allowed the separation of degradation products and aripiprazole and was defined as a stability-indicating method. The proposed method was validated for qualitative and quantitative analysis of aripiprazole and its degradation products. Accordingly, selectivity, linearity, precision, accuracy, limit of detection, limit of quantification, and robustness of the method were tested. The Box-Behnken experimental design was used in robustness testing.https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2023/0004-19632303216M.pdfaripiprazoleliquid chromatographybox-behnken experimental designforced degradation studydegradation products |
| spellingShingle | Mijatović Vesna Zečević Mira Zirojević Jelena Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products Arhiv za farmaciju aripiprazole liquid chromatography box-behnken experimental design forced degradation study degradation products |
| title | Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products |
| title_full | Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products |
| title_fullStr | Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products |
| title_full_unstemmed | Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products |
| title_short | Development and validation of a stability-indicating RP-HPLC method for determination of aripiprazole and its degradation products |
| title_sort | development and validation of a stability indicating rp hplc method for determination of aripiprazole and its degradation products |
| topic | aripiprazole liquid chromatography box-behnken experimental design forced degradation study degradation products |
| url | https://scindeks-clanci.ceon.rs/data/pdf/0004-1963/2023/0004-19632303216M.pdf |
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