Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method.
| Title: | Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method. |
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| Authors: | Gaikwad, Neha, Bhangale, Charushila, Bhandare, Sangita |
| Source: | International Journal of Pharmaceutical Investigation; Jan-Mar2024, Vol. 14 Issue 1, p151-159, 9p |
| Subject Terms: | AMLODIPINE, ENALAPRIL, MALEIC acid, RF values (Chromatography), HYDROCHLOROTHIAZIDE, CALCIUM antagonists, DETECTION limit |
| Abstract: | Objectives: The key objective of this work is to establish a stability-indicating UHPLC technique for measuring amlodipine and enalapril maleate in bulk and pharmaceutical formulations Materials and Methods: The mobile phase consisted of 0.02M KH2PO4 buffer: Methanol (70:30 v/v). The chromatographic separation was carried out using an Analytical Technologies UHPLC-3000 equipment in conjunction with a variable wavelength programmable UV identifier and a Rheodyne injector equipped with a 5 µL fixed circle. Detection was done at 224 nm with the flow rate of 0.3 mL/min. Results: Amlodipine's retention time was determined to be 0.7 min, while Enalapril's was 1.2 min. The linearity range for Amlodipine and Enalapril was discovered to be 5-25 µg/mL. The technique has been examined in accordance with ICH (International Conference on Harmonisation) standards. A procedure is precise and accurate if the %RSD is less than two. Amlodipine's limit of detection and quantitation ranges are 0.12-0.37 µg/mL and Enalapril's range is 0.10-0.30 µg/mL, respectively. The procedure proved to be simple, linear, swift, exact, accurate, repeatable, and reliable. The drug was prone to acid, basic, and oxidation conditions, according to the stress degradation research. Conclusion: Even in actual samples, the techniques clearly distinguished between the drugs and degradation products. The method was proved as a stability indicating method and can be used in practice for bulk and the dosage forms and also to evaluate the shelf life. [ABSTRACT FROM AUTHOR] |
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| Database: | Complementary Index |
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| Items | – Name: Title Label: Title Group: Ti Data: Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Gaikwad%2C+Neha%22">Gaikwad, Neha</searchLink><br /><searchLink fieldCode="AR" term="%22Bhangale%2C+Charushila%22">Bhangale, Charushila</searchLink><br /><searchLink fieldCode="AR" term="%22Bhandare%2C+Sangita%22">Bhandare, Sangita</searchLink> – Name: TitleSource Label: Source Group: Src Data: International Journal of Pharmaceutical Investigation; Jan-Mar2024, Vol. 14 Issue 1, p151-159, 9p – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22AMLODIPINE%22">AMLODIPINE</searchLink><br /><searchLink fieldCode="DE" term="%22ENALAPRIL%22">ENALAPRIL</searchLink><br /><searchLink fieldCode="DE" term="%22MALEIC+acid%22">MALEIC acid</searchLink><br /><searchLink fieldCode="DE" term="%22RF+values+%28Chromatography%29%22">RF values (Chromatography)</searchLink><br /><searchLink fieldCode="DE" term="%22HYDROCHLOROTHIAZIDE%22">HYDROCHLOROTHIAZIDE</searchLink><br /><searchLink fieldCode="DE" term="%22CALCIUM+antagonists%22">CALCIUM antagonists</searchLink><br /><searchLink fieldCode="DE" term="%22DETECTION+limit%22">DETECTION limit</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Objectives: The key objective of this work is to establish a stability-indicating UHPLC technique for measuring amlodipine and enalapril maleate in bulk and pharmaceutical formulations Materials and Methods: The mobile phase consisted of 0.02M KH2PO4 buffer: Methanol (70:30 v/v). The chromatographic separation was carried out using an Analytical Technologies UHPLC-3000 equipment in conjunction with a variable wavelength programmable UV identifier and a Rheodyne injector equipped with a 5 µL fixed circle. Detection was done at 224 nm with the flow rate of 0.3 mL/min. Results: Amlodipine's retention time was determined to be 0.7 min, while Enalapril's was 1.2 min. The linearity range for Amlodipine and Enalapril was discovered to be 5-25 µg/mL. The technique has been examined in accordance with ICH (International Conference on Harmonisation) standards. A procedure is precise and accurate if the %RSD is less than two. Amlodipine's limit of detection and quantitation ranges are 0.12-0.37 µg/mL and Enalapril's range is 0.10-0.30 µg/mL, respectively. The procedure proved to be simple, linear, swift, exact, accurate, repeatable, and reliable. The drug was prone to acid, basic, and oxidation conditions, according to the stress degradation research. Conclusion: Even in actual samples, the techniques clearly distinguished between the drugs and degradation products. The method was proved as a stability indicating method and can be used in practice for bulk and the dosage forms and also to evaluate the shelf life. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of International Journal of Pharmaceutical Investigation is the property of PHCOG.NET and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.5530/ijpi.14.1.19 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 9 StartPage: 151 Subjects: – SubjectFull: AMLODIPINE Type: general – SubjectFull: ENALAPRIL Type: general – SubjectFull: MALEIC acid Type: general – SubjectFull: RF values (Chromatography) Type: general – SubjectFull: HYDROCHLOROTHIAZIDE Type: general – SubjectFull: CALCIUM antagonists Type: general – SubjectFull: DETECTION limit Type: general Titles: – TitleFull: Simultaneous Estimation of Amlodipine and Enalapril Maleate by Stability Indicating UHPLC Method. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Gaikwad, Neha – PersonEntity: Name: NameFull: Bhangale, Charushila – PersonEntity: Name: NameFull: Bhandare, Sangita IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 01 Text: Jan-Mar2024 Type: published Y: 2024 Identifiers: – Type: issn-print Value: 2230973X Numbering: – Type: volume Value: 14 – Type: issue Value: 1 Titles: – TitleFull: International Journal of Pharmaceutical Investigation Type: main |
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