Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets
Two methods were developed for separation and quantitation of amlodipine (AML) and atorvastatin (ATV) in the presence of their acidic degradation products. The first method was a simple isocratic RP-HPLC method while the second was capillary electrophoresis (CE). Degradation products were obtained b...
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| Format: | Article |
| Language: | English |
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2016-12-01
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| Series: | Acta Pharmaceutica |
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| Online Access: | https://doi.org/10.1515/acph-2016-0040 |
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| author | Hassan Said A. Elzanfaly Eman S. El-Zeany Salem Badr A. Salem Maissa Y. |
| author_facet | Hassan Said A. Elzanfaly Eman S. El-Zeany Salem Badr A. Salem Maissa Y. |
| author_sort | Hassan Said A. |
| collection | DOAJ |
| description | Two methods were developed for separation and quantitation of amlodipine (AML) and atorvastatin (ATV) in the presence of their acidic degradation products. The first method was a simple isocratic RP-HPLC method while the second was capillary electrophoresis (CE). Degradation products were obtained by acidic hydrolysis of the two drugs and their structures were elucidated for the first time by IR and MS spectra. Degradation products did not interfere with the determination of either drug and the assays were therefore stability-indicating. The linearity of the proposed methods was established over the ranges 1-50 μg mL-1 for AML and ATV in the HPLC method and in the range of 3-50 and 4-50 μg mL-1 for AML and ATV, respectively, in the CE method. The proposed methods were validated according to ICH guidelines. The methods were successfully applied to estimation of AML and ATV in combined tablets. |
| format | Article |
| id | doaj-art-f8f5771aa4d5482585e6722707aa56d2 |
| institution | Kabale University |
| issn | 1846-9558 |
| language | English |
| publishDate | 2016-12-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj-art-f8f5771aa4d5482585e6722707aa56d22025-02-02T12:11:59ZengSciendoActa Pharmaceutica1846-95582016-12-0166447949010.1515/acph-2016-0040acph-2016-0040Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tabletsHassan Said A.0Elzanfaly Eman S.1El-Zeany Salem Badr A.2Salem Maissa Y.3Cairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, EgyptCairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, EgyptCairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, EgyptCairo University, Faculty of Pharmacy, Department of Analytical Chemistry, Kasr El-Aini Street, ET 11562, Cairo, EgyptTwo methods were developed for separation and quantitation of amlodipine (AML) and atorvastatin (ATV) in the presence of their acidic degradation products. The first method was a simple isocratic RP-HPLC method while the second was capillary electrophoresis (CE). Degradation products were obtained by acidic hydrolysis of the two drugs and their structures were elucidated for the first time by IR and MS spectra. Degradation products did not interfere with the determination of either drug and the assays were therefore stability-indicating. The linearity of the proposed methods was established over the ranges 1-50 μg mL-1 for AML and ATV in the HPLC method and in the range of 3-50 and 4-50 μg mL-1 for AML and ATV, respectively, in the CE method. The proposed methods were validated according to ICH guidelines. The methods were successfully applied to estimation of AML and ATV in combined tablets.https://doi.org/10.1515/acph-2016-0040atorvastatinamlodipinecapillary zone electrophoresishplcstabilityacidic degradation |
| spellingShingle | Hassan Said A. Elzanfaly Eman S. El-Zeany Salem Badr A. Salem Maissa Y. Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets Acta Pharmaceutica atorvastatin amlodipine capillary zone electrophoresis hplc stability acidic degradation |
| title | Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets |
| title_full | Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets |
| title_fullStr | Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets |
| title_full_unstemmed | Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets |
| title_short | Development and validation of HPLC and CE methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets |
| title_sort | development and validation of hplc and ce methods for simultaneous determination of amlodipine and atorvastatin in the presence of their acidic degradation products in tablets |
| topic | atorvastatin amlodipine capillary zone electrophoresis hplc stability acidic degradation |
| url | https://doi.org/10.1515/acph-2016-0040 |
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