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 |
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container_title | Tropical journal of pharmaceutical research |
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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 |
format | Article |
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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.</description><identifier>ISSN: 1596-5996</identifier><identifier>EISSN: 1596-9827</identifier><identifier>DOI: 10.4314/tjpr.v14i4.15</identifier><language>eng</language><publisher>Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria</publisher><subject>Amlodipine ; Precision ; Recovery ; Repeatability ; Reversed phase high performance liquid chromatography ; Validation</subject><ispartof>Tropical journal of pharmaceutical research, 2015-06, Vol.14 (4), p.663</ispartof><rights>Copyright 2015 - Tropical Journal of Pharmaceutical Research</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b315t-282952815754524b9d220b04c9e5bcbeeb7ade5e386b2179b9d18f8d986d6ab83</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,864,27924,27925,79426</link.rule.ids></links><search><creatorcontrib>Alaama, Mohamed</creatorcontrib><creatorcontrib>Uddin, ABM Helal</creatorcontrib><creatorcontrib>Mohamad, Huda Jamilah</creatorcontrib><creatorcontrib>Amiruddin, Noor Syafawati</creatorcontrib><creatorcontrib>Abbas, S.A</creatorcontrib><title>Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Determination of Amlodipine</title><title>Tropical journal of pharmaceutical research</title><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.</description><subject>Amlodipine</subject><subject>Precision</subject><subject>Recovery</subject><subject>Repeatability</subject><subject>Reversed phase high performance liquid chromatography</subject><subject>Validation</subject><issn>1596-5996</issn><issn>1596-9827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>RBI</sourceid><recordid>eNpFkFFLwzAQx4MoOKePvucLtDZp0yaPY1MnTByivoakua4ZbVPTOBC_vJ0bEw7uuPvx5_ghdEuSOEtJdhe2vY93JLNZTNgZmhAm8khwWpwfZyZEfomuhmGbJCwXgkzQzwJ20Li-hS5g1Rn8oRprVLCuw67Cr-PVD2DwulYD4KXd1HgNvnK-VV0JeGU_v6zB89q7VgW38aqvbYmfIdTO4BHDCwjgW9udImdt44ztbQfX6KJSzQA3xz5F7w_3b_NltHp5fJrPVpFOCQsR5VQwygkrWMZopoWhNNFJVgpgutQAulAGGKQ815QUYgQIr7gRPDe50jydouiQW3o3DB4q2XvbKv8tSSL35uTenPwzJwkb-fjAa-ua8c8TXnqr5P9yLMISXqS_uH52pA</recordid><startdate>20150619</startdate><enddate>20150619</enddate><creator>Alaama, Mohamed</creator><creator>Uddin, ABM Helal</creator><creator>Mohamad, Huda Jamilah</creator><creator>Amiruddin, Noor Syafawati</creator><creator>Abbas, S.A</creator><general>Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria</general><scope>RBI</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20150619</creationdate><title>Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Determination of Amlodipine</title><author>Alaama, Mohamed ; Uddin, ABM Helal ; Mohamad, Huda Jamilah ; Amiruddin, Noor Syafawati ; Abbas, S.A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b315t-282952815754524b9d220b04c9e5bcbeeb7ade5e386b2179b9d18f8d986d6ab83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Amlodipine</topic><topic>Precision</topic><topic>Recovery</topic><topic>Repeatability</topic><topic>Reversed phase high performance liquid chromatography</topic><topic>Validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Alaama, Mohamed</creatorcontrib><creatorcontrib>Uddin, ABM Helal</creatorcontrib><creatorcontrib>Mohamad, Huda Jamilah</creatorcontrib><creatorcontrib>Amiruddin, Noor Syafawati</creatorcontrib><creatorcontrib>Abbas, S.A</creatorcontrib><collection>Bioline International</collection><collection>CrossRef</collection><jtitle>Tropical journal of pharmaceutical research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Alaama, Mohamed</au><au>Uddin, ABM Helal</au><au>Mohamad, Huda Jamilah</au><au>Amiruddin, Noor Syafawati</au><au>Abbas, S.A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and Validation of Reversed Phase High Performance Liquid Chromatographic Method for Determination of Amlodipine</atitle><jtitle>Tropical journal of pharmaceutical research</jtitle><date>2015-06-19</date><risdate>2015</risdate><volume>14</volume><issue>4</issue><spage>663</spage><pages>663-</pages><issn>1596-5996</issn><eissn>1596-9827</eissn><abstract>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.</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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