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 besyl...

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Veröffentlicht in:Tropical journal of pharmaceutical research 2015-06, Vol.14 (4), p.663
Hauptverfasser: Alaama, Mohamed, Uddin, ABM Helal, Mohamad, Huda Jamilah, Amiruddin, Noor Syafawati, Abbas, S.A
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container_issue 4
container_start_page 663
container_title Tropical journal of pharmaceutical research
container_volume 14
creator Alaama, Mohamed
Uddin, ABM Helal
Mohamad, Huda Jamilah
Amiruddin, Noor Syafawati
Abbas, S.A
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.
doi_str_mv 10.4314/tjpr.v14i4.15
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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. 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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.</abstract><pub>Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria</pub><doi>10.4314/tjpr.v14i4.15</doi><oa>free_for_read</oa></addata></record>
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source African Journals Online (Open Access); Bioline International; DOAJ Directory of Open Access Journals; Free E-Journal (出版社公開部分のみ); Free Full-Text Journals in Chemistry
subjects Amlodipine
Precision
Recovery
Repeatability
Reversed phase high performance liquid chromatography
Validation
title Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Determination of Amlodipine
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