Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine

Purpose: To develop and validate a new sensitive and low-cost method for the analysis of amlodipine in tablet dosage form using reversed phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection. Methods: Standards and samples were prepared by dissolving amlodipine be...

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Main Authors: Alaama, Mohamed, Helal Uddin, A.B.M., Mohamad, Huda Jamilah, Amiruddin, Noor Syafawati, SA, Abbas
Format: Article
Language:English
Published: Pharmacotherapy Group, Faculty of Pharmacy, University of Benin 2015
Subjects:
Online Access:http://irep.iium.edu.my/43812/
http://irep.iium.edu.my/43812/1/TJPR_Amlodipine_2015.pdf
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author Alaama, Mohamed
Helal Uddin, A.B.M.
Mohamad, Huda Jamilah
Amiruddin, Noor Syafawati
SA, Abbas
author_facet Alaama, Mohamed
Helal Uddin, A.B.M.
Mohamad, Huda Jamilah
Amiruddin, Noor Syafawati
SA, Abbas
author_sort Alaama, Mohamed
building IIUM Repository
collection Online Access
description Purpose: To develop and validate a new sensitive and low-cost method for the analysis of amlodipine in tablet dosage form using reversed phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection. Methods: Standards and samples were prepared by dissolving amlodipine besylate standard or amlodipine tablets in mobile phase and sonicated for 5 min. The samples were analysed by RP-HPLC equipped with quaternary pump and auto-injector. Separation was achieved using C18 column, and the mobile phase consisted of ammonium acetate buffer containing 0.02 % triethylamine TEA (pH = 4, adjusted using glacial acetic acid) and acetonitrile in the ratio 60:40 v/v. The flow rate was 1 ml/min and a UV detector was used for the detection of amlodipine at a wavelength of 248 nm. The method was validated according to International Conference of Harmonization (ICH) guidelines. Results: The retention time for amlodipine peak was 3.44 ± 0.41 min with a total run time of 6 min. The method was linear over the range of 0.5 - 40 μg/ml with coefficient of determination (R2) of 0.999. Recovery was 98.09 - 100.19 %, and the method showed high precision and repeatability. All validated parameters were within the range of ICH requirements. Conclusion: A new rapid sensitive and low-cost method has been developed and validated for the analysis of amlodipine in tablet dosage form.
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spelling iium-438122022-11-07T03:26:31Z http://irep.iium.edu.my/43812/ Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine Alaama, Mohamed Helal Uddin, A.B.M. Mohamad, Huda Jamilah Amiruddin, Noor Syafawati SA, Abbas QD Chemistry RS Pharmacy and materia medica Purpose: To develop and validate a new sensitive and low-cost method for the analysis of amlodipine in tablet dosage form using reversed phase high performance liquid chromatography (RP-HPLC) with ultraviolet (UV) detection. Methods: Standards and samples were prepared by dissolving amlodipine besylate standard or amlodipine tablets in mobile phase and sonicated for 5 min. The samples were analysed by RP-HPLC equipped with quaternary pump and auto-injector. Separation was achieved using C18 column, and the mobile phase consisted of ammonium acetate buffer containing 0.02 % triethylamine TEA (pH = 4, adjusted using glacial acetic acid) and acetonitrile in the ratio 60:40 v/v. The flow rate was 1 ml/min and a UV detector was used for the detection of amlodipine at a wavelength of 248 nm. The method was validated according to International Conference of Harmonization (ICH) guidelines. Results: The retention time for amlodipine peak was 3.44 ± 0.41 min with a total run time of 6 min. The method was linear over the range of 0.5 - 40 μg/ml with coefficient of determination (R2) of 0.999. Recovery was 98.09 - 100.19 %, and the method showed high precision and repeatability. All validated parameters were within the range of ICH requirements. Conclusion: A new rapid sensitive and low-cost method has been developed and validated for the analysis of amlodipine in tablet dosage form. Pharmacotherapy Group, Faculty of Pharmacy, University of Benin 2015 Article PeerReviewed application/pdf en http://irep.iium.edu.my/43812/1/TJPR_Amlodipine_2015.pdf Alaama, Mohamed and Helal Uddin, A.B.M. and Mohamad, Huda Jamilah and Amiruddin, Noor Syafawati and SA, Abbas (2015) Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine. Tropical Journal of Pharmaceutical Research, 14 (4). pp. 663-669. ISSN 1596-9827 (O), 1596-5996 (P) http://dx.doi.org/10.4314/tjpr.v14i4.15
spellingShingle QD Chemistry
RS Pharmacy and materia medica
Alaama, Mohamed
Helal Uddin, A.B.M.
Mohamad, Huda Jamilah
Amiruddin, Noor Syafawati
SA, Abbas
Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
title Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
title_full Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
title_fullStr Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
title_full_unstemmed Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
title_short Development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
title_sort development and validation of reversed phase high performance liquid chromatographic method for determination of amlodipine
topic QD Chemistry
RS Pharmacy and materia medica
url http://irep.iium.edu.my/43812/
http://irep.iium.edu.my/43812/
http://irep.iium.edu.my/43812/1/TJPR_Amlodipine_2015.pdf