Quality by design‐based development and validation of an HPLC method for simultaneous estimation of pregabalin and piperine in dual drug‐loaded liposomes
The current research work describes the development of a rapid HPLC method for the concurrent detection of pregabalin and piperine in dual drug‐loaded nanoformulations. The primary goal was to recognize the chromatographic conditions wherein propitious segregation of the integrants with quality peak...
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description | The current research work describes the development of a rapid HPLC method for the concurrent detection of pregabalin and piperine in dual drug‐loaded nanoformulations. The primary goal was to recognize the chromatographic conditions wherein propitious segregation of the integrants with quality peaks can be attained. An attempt to expound the target analytical profile was made to accomplish this goal, and critical method attributes (CMAs), viz. percentage acetonitrile content, injection volume and pH, which affect critical quality attributes (CQAs), were identified using systemic risk analysis. Box–Behnken design was employed to develop a relationship between CMAs and CQAs, which engenders an analytical design space. Efficient chromatographic separation for pregabalin and piperine was attained using an analytical C18 column and mobile phase comprising acetonitrile–water (pH 6.9; 70:30%, v/v) in an isocratic elution mode with a 1 ml/min flow rate. The elution was descried at an isosbestic wavelength of 221 nm using a photodiode array detector. The International Conference on Harmonization guidelines were adopted for the developed HPLC method. The validated HPLC method can be further utilized for the simultaneous quantification and detection of pregabalin and piperine in other lipid‐based nanopharmaceuticals such as polymeric nanoparticles, nanocrystals, solid‐lipid nanoparticles, metallic nanoparticles, etc., in in vitro and in vivo studies. |
doi_str_mv | 10.1002/bmc.5510 |
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The primary goal was to recognize the chromatographic conditions wherein propitious segregation of the integrants with quality peaks can be attained. An attempt to expound the target analytical profile was made to accomplish this goal, and critical method attributes (CMAs), viz. percentage acetonitrile content, injection volume and pH, which affect critical quality attributes (CQAs), were identified using systemic risk analysis. Box–Behnken design was employed to develop a relationship between CMAs and CQAs, which engenders an analytical design space. Efficient chromatographic separation for pregabalin and piperine was attained using an analytical C18 column and mobile phase comprising acetonitrile–water (pH 6.9; 70:30%, v/v) in an isocratic elution mode with a 1 ml/min flow rate. The elution was descried at an isosbestic wavelength of 221 nm using a photodiode array detector. The International Conference on Harmonization guidelines were adopted for the developed HPLC method. 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The primary goal was to recognize the chromatographic conditions wherein propitious segregation of the integrants with quality peaks can be attained. An attempt to expound the target analytical profile was made to accomplish this goal, and critical method attributes (CMAs), viz. percentage acetonitrile content, injection volume and pH, which affect critical quality attributes (CQAs), were identified using systemic risk analysis. Box–Behnken design was employed to develop a relationship between CMAs and CQAs, which engenders an analytical design space. Efficient chromatographic separation for pregabalin and piperine was attained using an analytical C18 column and mobile phase comprising acetonitrile–water (pH 6.9; 70:30%, v/v) in an isocratic elution mode with a 1 ml/min flow rate. The elution was descried at an isosbestic wavelength of 221 nm using a photodiode array detector. The International Conference on Harmonization guidelines were adopted for the developed HPLC method. The validated HPLC method can be further utilized for the simultaneous quantification and detection of pregabalin and piperine in other lipid‐based nanopharmaceuticals such as polymeric nanoparticles, nanocrystals, solid‐lipid nanoparticles, metallic nanoparticles, etc., in in vitro and in vivo studies.</description><subject>Acetonitriles</subject><subject>Box–Behnken design</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>HPLC</subject><subject>Limit of Detection</subject><subject>Lipids</subject><subject>Liposomes</subject><subject>piperine</subject><subject>Pregabalin</subject><subject>QbD</subject><subject>Reproducibility of Results</subject><subject>simultaneous estimation</subject><issn>0269-3879</issn><issn>1099-0801</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtOHDEQhq0IFAYSKSeIvGTTxG7P-LEMIxKQBhEksm75UT0YuduN3U00uxwhF-BynCSGAcSGlVXW56_qdyH0hZIjSkj9zXT2aLGg5AOaUaJURSShO2hGaq4qJoXaQ_s53xBCFK_FR7THeHkmmJih-8tJBz9usNlgB9mv-4e__4zO4Ep5ByEOHfQj1r3DdwV0evSxx7EtN_j012qJOxivo8NtTDj7bgqj7iFOGUMeffdKDwnW2hRB_6Qa_ADJ94BL7coA2KVpXRqHqF3pHPwQc-wgf0K7rQ4ZPj-fB-j3j5Or5Wm1uvh5tvy-qiyrKam40wSkVFqWYPO5pHIhtGiZllQI4MzWRlqgdm6lMtRaqBV12iiuOOWGE3aADrfeIcXbqYzedD5bCGEbpqkFnTMpF-wNalPMOUHbDKkETZuGkuZxGU1ZRvO4jIJ-fbZOpgP3Cr78fgGqLfDHB9i8K2qOz5dPwv-fKpdG</recordid><startdate>202301</startdate><enddate>202301</enddate><creator>Gupta, Isha</creator><creator>Adin, Syeda Nashvia</creator><creator>Aqil, Mohd</creator><creator>Mujeeb, Mohd</creator><creator>Sultana, Yasmin</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7857-1124</orcidid><orcidid>https://orcid.org/0000-0001-6797-3104</orcidid><orcidid>https://orcid.org/0000-0001-7204-780X</orcidid><orcidid>https://orcid.org/0000-0002-2987-2967</orcidid></search><sort><creationdate>202301</creationdate><title>Quality by design‐based development and validation of an HPLC method for simultaneous estimation of pregabalin and piperine in dual drug‐loaded liposomes</title><author>Gupta, Isha ; Adin, Syeda Nashvia ; Aqil, Mohd ; Mujeeb, Mohd ; Sultana, Yasmin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3210-6da0e889a83614481857a7f3a8177e63c2b8ce1c4c89b1cce291dab969616b603</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Acetonitriles</topic><topic>Box–Behnken design</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>HPLC</topic><topic>Limit of Detection</topic><topic>Lipids</topic><topic>Liposomes</topic><topic>piperine</topic><topic>Pregabalin</topic><topic>QbD</topic><topic>Reproducibility of Results</topic><topic>simultaneous estimation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gupta, Isha</creatorcontrib><creatorcontrib>Adin, Syeda Nashvia</creatorcontrib><creatorcontrib>Aqil, Mohd</creatorcontrib><creatorcontrib>Mujeeb, Mohd</creatorcontrib><creatorcontrib>Sultana, Yasmin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Biomedical chromatography</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gupta, Isha</au><au>Adin, Syeda Nashvia</au><au>Aqil, Mohd</au><au>Mujeeb, Mohd</au><au>Sultana, Yasmin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality by design‐based development and validation of an HPLC method for simultaneous estimation of pregabalin and piperine in dual drug‐loaded liposomes</atitle><jtitle>Biomedical chromatography</jtitle><addtitle>Biomed Chromatogr</addtitle><date>2023-01</date><risdate>2023</risdate><volume>37</volume><issue>1</issue><spage>e5510</spage><epage>n/a</epage><pages>e5510-n/a</pages><issn>0269-3879</issn><eissn>1099-0801</eissn><abstract>The current research work describes the development of a rapid HPLC method for the concurrent detection of pregabalin and piperine in dual drug‐loaded nanoformulations. The primary goal was to recognize the chromatographic conditions wherein propitious segregation of the integrants with quality peaks can be attained. An attempt to expound the target analytical profile was made to accomplish this goal, and critical method attributes (CMAs), viz. percentage acetonitrile content, injection volume and pH, which affect critical quality attributes (CQAs), were identified using systemic risk analysis. Box–Behnken design was employed to develop a relationship between CMAs and CQAs, which engenders an analytical design space. Efficient chromatographic separation for pregabalin and piperine was attained using an analytical C18 column and mobile phase comprising acetonitrile–water (pH 6.9; 70:30%, v/v) in an isocratic elution mode with a 1 ml/min flow rate. The elution was descried at an isosbestic wavelength of 221 nm using a photodiode array detector. The International Conference on Harmonization guidelines were adopted for the developed HPLC method. The validated HPLC method can be further utilized for the simultaneous quantification and detection of pregabalin and piperine in other lipid‐based nanopharmaceuticals such as polymeric nanoparticles, nanocrystals, solid‐lipid nanoparticles, metallic nanoparticles, etc., in in vitro and in vivo studies.</abstract><cop>England</cop><pmid>36100737</pmid><doi>10.1002/bmc.5510</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-7857-1124</orcidid><orcidid>https://orcid.org/0000-0001-6797-3104</orcidid><orcidid>https://orcid.org/0000-0001-7204-780X</orcidid><orcidid>https://orcid.org/0000-0002-2987-2967</orcidid></addata></record> |
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subjects | Acetonitriles Box–Behnken design Chromatography, High Pressure Liquid - methods HPLC Limit of Detection Lipids Liposomes piperine Pregabalin QbD Reproducibility of Results simultaneous estimation |
title | Quality by design‐based development and validation of an HPLC method for simultaneous estimation of pregabalin and piperine in dual drug‐loaded liposomes |
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