Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs
Abstract Background The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. A...
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creator | Prajapati, Pintu Jariwala, Hetal Prajapati, Bhumika Salunkhe, Minal Pulusu, Veera Shakar Shah, Shailesh |
description | Abstract
Background
The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. According to the concept of green analytical chemistry (GAC), toxic organic solvents should be avoided or minimized during chromatographic method development for the safety of analysts and the protection of the environment. The reported RP-HPLC methods have been developed using acetonitrile (ACN) or methanol as an organic component of the mobile phase and diluent for sample preparation. These organic solvents are considered toxic solvents as per the International Council for Harmonization (ICH) Q3C (R6) guideline and Pfizer medicinal chemistry solvent selection (PMCSS) guide.
Objective
We aimed to develop an environment-friendly and economical RP-HPLC–photo-diode array (PDA) method for the analysis of MTS, CDN, and TST using less toxic organic solvents to support the concept of GAC.
Methods
The method development was carried out by the implementation of chemometrics and design of experiments (DoE) to avoid wastage of organic solvent. Principal component analysis (PCA) was applied as a chemometric tool for the identification of critical method risk variables (MRVs) and method performance attributes (MPAs). The identified critical MRVs and MPAs were further studied by DoE-based response surface modelling for optimization of the method.
Results
The chromatographic analysis of MTS, CDN, and TST was carried out using a Shim-pack ODS column as a stationary phase and ethanol as an organic modifier in the mobile phase. The developed method was applied to the assay of FDCs and results were found to be in compliance with the label claim. The greenness profiles of reported and present RP-HPLC methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods.
Conclusion
The developed method was found to be green, robust, and economical as compared to published methods for the analysis.
Highlights
Development and validation of an RP-HPLC method for simultaneous estimation of MTS, CDN, and TST using safe organic solvents. Implementation of a analytical quality by design (AQbD) approach in method development using PCA and DoE. Application of the method for assay of FDCs of MTS, CDN, and TST. |
doi_str_mv | 10.1093/jaoacint/qsad016 |
format | Article |
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Background
The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. According to the concept of green analytical chemistry (GAC), toxic organic solvents should be avoided or minimized during chromatographic method development for the safety of analysts and the protection of the environment. The reported RP-HPLC methods have been developed using acetonitrile (ACN) or methanol as an organic component of the mobile phase and diluent for sample preparation. These organic solvents are considered toxic solvents as per the International Council for Harmonization (ICH) Q3C (R6) guideline and Pfizer medicinal chemistry solvent selection (PMCSS) guide.
Objective
We aimed to develop an environment-friendly and economical RP-HPLC–photo-diode array (PDA) method for the analysis of MTS, CDN, and TST using less toxic organic solvents to support the concept of GAC.
Methods
The method development was carried out by the implementation of chemometrics and design of experiments (DoE) to avoid wastage of organic solvent. Principal component analysis (PCA) was applied as a chemometric tool for the identification of critical method risk variables (MRVs) and method performance attributes (MPAs). The identified critical MRVs and MPAs were further studied by DoE-based response surface modelling for optimization of the method.
Results
The chromatographic analysis of MTS, CDN, and TST was carried out using a Shim-pack ODS column as a stationary phase and ethanol as an organic modifier in the mobile phase. The developed method was applied to the assay of FDCs and results were found to be in compliance with the label claim. The greenness profiles of reported and present RP-HPLC methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods.
Conclusion
The developed method was found to be green, robust, and economical as compared to published methods for the analysis.
Highlights
Development and validation of an RP-HPLC method for simultaneous estimation of MTS, CDN, and TST using safe organic solvents. Implementation of a analytical quality by design (AQbD) approach in method development using PCA and DoE. Application of the method for assay of FDCs of MTS, CDN, and TST.</description><identifier>ISSN: 1060-3271</identifier><identifier>EISSN: 1944-7922</identifier><identifier>DOI: 10.1093/jaoacint/qsad016</identifier><identifier>PMID: 36655771</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Antihypertensive Agents ; Chromatography, High Pressure Liquid - methods ; Ethanol - chemistry ; Methanol ; Principal Component Analysis ; Solvents - chemistry ; Telmisartan</subject><ispartof>Journal of AOAC International, 2023-07, Vol.106 (4), p.1087-1097</ispartof><rights>The Author(s) 2023. Published by Oxford University Press on behalf of AOAC INTERNATIONAL. All rights reserved. For permissions, please email: journals.permissions@oup.com 2023</rights><rights>The Author(s) 2023. Published by Oxford University Press on behalf of AOAC INTERNATIONAL. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0003-0175-6697 ; 0000-0001-9648-5724 ; 0000-0002-5282-2087 ; 0000-0002-1039-9882 ; 0000-0003-0125-6661 ; 0000-0003-1801-6388</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36655771$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Prajapati, Pintu</creatorcontrib><creatorcontrib>Jariwala, Hetal</creatorcontrib><creatorcontrib>Prajapati, Bhumika</creatorcontrib><creatorcontrib>Salunkhe, Minal</creatorcontrib><creatorcontrib>Pulusu, Veera Shakar</creatorcontrib><creatorcontrib>Shah, Shailesh</creatorcontrib><title>Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs</title><title>Journal of AOAC International</title><addtitle>J AOAC Int</addtitle><description>Abstract
Background
The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. According to the concept of green analytical chemistry (GAC), toxic organic solvents should be avoided or minimized during chromatographic method development for the safety of analysts and the protection of the environment. The reported RP-HPLC methods have been developed using acetonitrile (ACN) or methanol as an organic component of the mobile phase and diluent for sample preparation. These organic solvents are considered toxic solvents as per the International Council for Harmonization (ICH) Q3C (R6) guideline and Pfizer medicinal chemistry solvent selection (PMCSS) guide.
Objective
We aimed to develop an environment-friendly and economical RP-HPLC–photo-diode array (PDA) method for the analysis of MTS, CDN, and TST using less toxic organic solvents to support the concept of GAC.
Methods
The method development was carried out by the implementation of chemometrics and design of experiments (DoE) to avoid wastage of organic solvent. Principal component analysis (PCA) was applied as a chemometric tool for the identification of critical method risk variables (MRVs) and method performance attributes (MPAs). The identified critical MRVs and MPAs were further studied by DoE-based response surface modelling for optimization of the method.
Results
The chromatographic analysis of MTS, CDN, and TST was carried out using a Shim-pack ODS column as a stationary phase and ethanol as an organic modifier in the mobile phase. The developed method was applied to the assay of FDCs and results were found to be in compliance with the label claim. The greenness profiles of reported and present RP-HPLC methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods.
Conclusion
The developed method was found to be green, robust, and economical as compared to published methods for the analysis.
Highlights
Development and validation of an RP-HPLC method for simultaneous estimation of MTS, CDN, and TST using safe organic solvents. Implementation of a analytical quality by design (AQbD) approach in method development using PCA and DoE. Application of the method for assay of FDCs of MTS, CDN, and TST.</description><subject>Antihypertensive Agents</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Ethanol - chemistry</subject><subject>Methanol</subject><subject>Principal Component Analysis</subject><subject>Solvents - chemistry</subject><subject>Telmisartan</subject><issn>1060-3271</issn><issn>1944-7922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9UcFOwzAMjRCIjcGdE8odlSVpl7bHqRsb0hAc4FylbbJlapMsSZH6Y3wfgY1dbMvPfn7yA-AeoyeM8ni6Z5rVUvnpwbEGYXoBxjhPkijNCbkMNaIoikmKR-DGuT1CCaaIXINRTOlslqZ4DL7nxrSyZl5qBbWA71aqWhrWwkJ3RiuuPJwr1g5OOshUAxd6GS2s_OIKriwP8Q_1gSKs7HgnnbdDWFY1Nx56DTfy0MsmYFZ3zOutZWYna_jK_U43UGgLl87L7qyg0FFodn3LPG8Cu5fRejDceq5cOAsXtt-6W3AlWOv43SlPwOfz8qNYR5u31Usx30SaJKmPakJpxSgVOWKVIDnJhYg5iWc1ZlUePkNwldUCcSYyREXGc5wklCVZRZokbkg8AQ9HXtNXHW9KY4NSO5T_DwwDj8cB3ZszilH5a0_5b095sif-Afl9iF0</recordid><startdate>20230717</startdate><enddate>20230717</enddate><creator>Prajapati, Pintu</creator><creator>Jariwala, Hetal</creator><creator>Prajapati, Bhumika</creator><creator>Salunkhe, Minal</creator><creator>Pulusu, Veera Shakar</creator><creator>Shah, Shailesh</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><orcidid>https://orcid.org/0000-0003-0175-6697</orcidid><orcidid>https://orcid.org/0000-0001-9648-5724</orcidid><orcidid>https://orcid.org/0000-0002-5282-2087</orcidid><orcidid>https://orcid.org/0000-0002-1039-9882</orcidid><orcidid>https://orcid.org/0000-0003-0125-6661</orcidid><orcidid>https://orcid.org/0000-0003-1801-6388</orcidid></search><sort><creationdate>20230717</creationdate><title>Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs</title><author>Prajapati, Pintu ; Jariwala, Hetal ; Prajapati, Bhumika ; Salunkhe, Minal ; Pulusu, Veera Shakar ; Shah, Shailesh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-o247t-c266ba66f90abf2929ff3e235c1ab932721b8cf0eaf806f8e91446a48b2d43d23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Antihypertensive Agents</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Ethanol - chemistry</topic><topic>Methanol</topic><topic>Principal Component Analysis</topic><topic>Solvents - chemistry</topic><topic>Telmisartan</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Prajapati, Pintu</creatorcontrib><creatorcontrib>Jariwala, Hetal</creatorcontrib><creatorcontrib>Prajapati, Bhumika</creatorcontrib><creatorcontrib>Salunkhe, Minal</creatorcontrib><creatorcontrib>Pulusu, Veera Shakar</creatorcontrib><creatorcontrib>Shah, Shailesh</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Journal of AOAC International</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Prajapati, Pintu</au><au>Jariwala, Hetal</au><au>Prajapati, Bhumika</au><au>Salunkhe, Minal</au><au>Pulusu, Veera Shakar</au><au>Shah, Shailesh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs</atitle><jtitle>Journal of AOAC International</jtitle><addtitle>J AOAC Int</addtitle><date>2023-07-17</date><risdate>2023</risdate><volume>106</volume><issue>4</issue><spage>1087</spage><epage>1097</epage><pages>1087-1097</pages><issn>1060-3271</issn><eissn>1944-7922</eissn><abstract>Abstract
Background
The fixed-dose combination (FDC) of metoprolol succinate (MTS), cilnidipine (CDN), and telmisartan (TST) is used for the management of hypertension. Numerous reversed phase (RP)-HPLC methods have been reported in the literature for chromatographic analysis of MTS, CDN, and TST. According to the concept of green analytical chemistry (GAC), toxic organic solvents should be avoided or minimized during chromatographic method development for the safety of analysts and the protection of the environment. The reported RP-HPLC methods have been developed using acetonitrile (ACN) or methanol as an organic component of the mobile phase and diluent for sample preparation. These organic solvents are considered toxic solvents as per the International Council for Harmonization (ICH) Q3C (R6) guideline and Pfizer medicinal chemistry solvent selection (PMCSS) guide.
Objective
We aimed to develop an environment-friendly and economical RP-HPLC–photo-diode array (PDA) method for the analysis of MTS, CDN, and TST using less toxic organic solvents to support the concept of GAC.
Methods
The method development was carried out by the implementation of chemometrics and design of experiments (DoE) to avoid wastage of organic solvent. Principal component analysis (PCA) was applied as a chemometric tool for the identification of critical method risk variables (MRVs) and method performance attributes (MPAs). The identified critical MRVs and MPAs were further studied by DoE-based response surface modelling for optimization of the method.
Results
The chromatographic analysis of MTS, CDN, and TST was carried out using a Shim-pack ODS column as a stationary phase and ethanol as an organic modifier in the mobile phase. The developed method was applied to the assay of FDCs and results were found to be in compliance with the label claim. The greenness profiles of reported and present RP-HPLC methods were evaluated by national environmental method index (NEMI) and analytical greenness (AGREE) methods.
Conclusion
The developed method was found to be green, robust, and economical as compared to published methods for the analysis.
Highlights
Development and validation of an RP-HPLC method for simultaneous estimation of MTS, CDN, and TST using safe organic solvents. Implementation of a analytical quality by design (AQbD) approach in method development using PCA and DoE. Application of the method for assay of FDCs of MTS, CDN, and TST.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>36655771</pmid><doi>10.1093/jaoacint/qsad016</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-0175-6697</orcidid><orcidid>https://orcid.org/0000-0001-9648-5724</orcidid><orcidid>https://orcid.org/0000-0002-5282-2087</orcidid><orcidid>https://orcid.org/0000-0002-1039-9882</orcidid><orcidid>https://orcid.org/0000-0003-0125-6661</orcidid><orcidid>https://orcid.org/0000-0003-1801-6388</orcidid></addata></record> |
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source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
subjects | Antihypertensive Agents Chromatography, High Pressure Liquid - methods Ethanol - chemistry Methanol Principal Component Analysis Solvents - chemistry Telmisartan |
title | Application of Principal Component Analysis and DoE-Driven Green Analytical Chemistry Concept to Liquid Chromatographic Method for Estimation of Co-formulated Anti-Hypertensive Drugs |
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