Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection
A simple and rapid high-performance liquid chromatographic method for the separation and determination of piracetam and its four impurities, 2-oxopyrrolidin-1-yl)acetic acid, pyrrolidin-2-one, methyl (2-oxopyrrolidin-1-yl)acetate, and ethyl (2-oxopyrrolidin-1-yl)acetate, was developed. The separatio...
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Veröffentlicht in: | Journal of chromatographic science 2010-08, Vol.48 (7), p.589-594 |
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description | A simple and rapid high-performance liquid chromatographic method for the separation and determination of piracetam and its four impurities, 2-oxopyrrolidin-1-yl)acetic acid, pyrrolidin-2-one, methyl (2-oxopyrrolidin-1-yl)acetate, and ethyl (2-oxopyrrolidin-1-yl)acetate, was developed. The separation was achieved on a reversed-phase C18 Nucleosil column (25 cm × 0.46 cm, 10 μm). The mobile phase is composed of an aqueous solution containing 0.2 g/L of triethyl amine.acetonitrile (85:15, v/v). The pH of the mobile phase was adjusted to 6.5 with phosphoric acid at a flow rate of 1 mL/min at ambient temperature and UV detection at 205 nm. The developed method was found to give good separation between the pure drug and its four related substance. The polynomial regression data for the calibration plots showed good linear relationship in the concentration range of 50.10,000 ng/mL, 25.10,000 ng/mL, 45.10,000 ng/mL, 34.10,000 ng/mL, and 55.10,000 ng/mL, respectively, with r2 = 0.9999. The method was validated for precision, accuracy, ruggedness, and recovery. The minimum quantifiable amounts were found to be 50 ng/mL of piracetam, 25 ng/mL of 2-oxopyrrolidin-1-yl)acetic acid, 45 ng/mL of pyrrolidin-2-one, 34 ng/mL of methyl (2-oxopyrrolidin-1-yl)acetate, and 55 ng/mL of ethyl (2-oxopyrrolidin-1-yl)acetate. Statistical analysis proves that the method is reproducible and selective for the estimation of piracetam as well as its related substance. As the method could effectively separate the drug from the related substances, it can be employed as a stability-indicating one. The proposed method shows high efficiency, allowing the separation of the main component piracetam from other impurities. |
doi_str_mv | 10.1093/chromsci/48.7.589 |
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Saeed ; Sultana, Najma ; Siddiqui, Farhan Ahmed ; Mirza, Agha Zeeshan ; Qureshi, Faiza ; Zuberi, M. Hashim</creator><creatorcontrib>Arayne, M. Saeed ; Sultana, Najma ; Siddiqui, Farhan Ahmed ; Mirza, Agha Zeeshan ; Qureshi, Faiza ; Zuberi, M. Hashim</creatorcontrib><description>A simple and rapid high-performance liquid chromatographic method for the separation and determination of piracetam and its four impurities, 2-oxopyrrolidin-1-yl)acetic acid, pyrrolidin-2-one, methyl (2-oxopyrrolidin-1-yl)acetate, and ethyl (2-oxopyrrolidin-1-yl)acetate, was developed. The separation was achieved on a reversed-phase C18 Nucleosil column (25 cm × 0.46 cm, 10 μm). The mobile phase is composed of an aqueous solution containing 0.2 g/L of triethyl amine.acetonitrile (85:15, v/v). The pH of the mobile phase was adjusted to 6.5 with phosphoric acid at a flow rate of 1 mL/min at ambient temperature and UV detection at 205 nm. The developed method was found to give good separation between the pure drug and its four related substance. The polynomial regression data for the calibration plots showed good linear relationship in the concentration range of 50.10,000 ng/mL, 25.10,000 ng/mL, 45.10,000 ng/mL, 34.10,000 ng/mL, and 55.10,000 ng/mL, respectively, with r2 = 0.9999. The method was validated for precision, accuracy, ruggedness, and recovery. The minimum quantifiable amounts were found to be 50 ng/mL of piracetam, 25 ng/mL of 2-oxopyrrolidin-1-yl)acetic acid, 45 ng/mL of pyrrolidin-2-one, 34 ng/mL of methyl (2-oxopyrrolidin-1-yl)acetate, and 55 ng/mL of ethyl (2-oxopyrrolidin-1-yl)acetate. Statistical analysis proves that the method is reproducible and selective for the estimation of piracetam as well as its related substance. As the method could effectively separate the drug from the related substances, it can be employed as a stability-indicating one. The proposed method shows high efficiency, allowing the separation of the main component piracetam from other impurities.</description><identifier>ISSN: 0021-9665</identifier><identifier>EISSN: 1945-239X</identifier><identifier>DOI: 10.1093/chromsci/48.7.589</identifier><identifier>PMID: 20819285</identifier><identifier>CODEN: JCHSBZ</identifier><language>eng</language><publisher>Niles, IL: Oxford University Press</publisher><subject>Acetic Acid - analysis ; Acetic Acid - chemistry ; Analysis ; Biological and medical sciences ; Chromatography, High Pressure Liquid - methods ; Chromatography, Reverse-Phase - methods ; Drug Contamination ; Drug Stability ; General pharmacology ; Hydrogen-Ion Concentration ; Linear Models ; Medical sciences ; Pharmacology. Drug treatments ; Piracetam - analysis ; Piracetam - chemistry ; Pyrrolidinones - analysis ; Pyrrolidinones - chemistry ; Reproducibility of Results ; Spectrophotometry, Ultraviolet</subject><ispartof>Journal of chromatographic science, 2010-08, Vol.48 (7), p.589-594</ispartof><rights>2010</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c448t-c4a9e00154e9dc188891d7d4fc292ad1092e4e079a0c8583c6bbf2cab9fcf793</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1584,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23059674$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20819285$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Arayne, M. Saeed</creatorcontrib><creatorcontrib>Sultana, Najma</creatorcontrib><creatorcontrib>Siddiqui, Farhan Ahmed</creatorcontrib><creatorcontrib>Mirza, Agha Zeeshan</creatorcontrib><creatorcontrib>Qureshi, Faiza</creatorcontrib><creatorcontrib>Zuberi, M. Hashim</creatorcontrib><title>Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection</title><title>Journal of chromatographic science</title><addtitle>Journal of Chromatographic Science</addtitle><addtitle>Journal of Chromatographic Science</addtitle><description>A simple and rapid high-performance liquid chromatographic method for the separation and determination of piracetam and its four impurities, 2-oxopyrrolidin-1-yl)acetic acid, pyrrolidin-2-one, methyl (2-oxopyrrolidin-1-yl)acetate, and ethyl (2-oxopyrrolidin-1-yl)acetate, was developed. The separation was achieved on a reversed-phase C18 Nucleosil column (25 cm × 0.46 cm, 10 μm). The mobile phase is composed of an aqueous solution containing 0.2 g/L of triethyl amine.acetonitrile (85:15, v/v). The pH of the mobile phase was adjusted to 6.5 with phosphoric acid at a flow rate of 1 mL/min at ambient temperature and UV detection at 205 nm. The developed method was found to give good separation between the pure drug and its four related substance. The polynomial regression data for the calibration plots showed good linear relationship in the concentration range of 50.10,000 ng/mL, 25.10,000 ng/mL, 45.10,000 ng/mL, 34.10,000 ng/mL, and 55.10,000 ng/mL, respectively, with r2 = 0.9999. The method was validated for precision, accuracy, ruggedness, and recovery. The minimum quantifiable amounts were found to be 50 ng/mL of piracetam, 25 ng/mL of 2-oxopyrrolidin-1-yl)acetic acid, 45 ng/mL of pyrrolidin-2-one, 34 ng/mL of methyl (2-oxopyrrolidin-1-yl)acetate, and 55 ng/mL of ethyl (2-oxopyrrolidin-1-yl)acetate. Statistical analysis proves that the method is reproducible and selective for the estimation of piracetam as well as its related substance. As the method could effectively separate the drug from the related substances, it can be employed as a stability-indicating one. The proposed method shows high efficiency, allowing the separation of the main component piracetam from other impurities.</description><subject>Acetic Acid - analysis</subject><subject>Acetic Acid - chemistry</subject><subject>Analysis</subject><subject>Biological and medical sciences</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Chromatography, Reverse-Phase - methods</subject><subject>Drug Contamination</subject><subject>Drug Stability</subject><subject>General pharmacology</subject><subject>Hydrogen-Ion Concentration</subject><subject>Linear Models</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Piracetam - analysis</subject><subject>Piracetam - chemistry</subject><subject>Pyrrolidinones - analysis</subject><subject>Pyrrolidinones - chemistry</subject><subject>Reproducibility of Results</subject><subject>Spectrophotometry, Ultraviolet</subject><issn>0021-9665</issn><issn>1945-239X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkEtrGzEUhUVpaJykP6CboE3JpuNIM9JIWgY7rgOGmLwwpSA0Gg1WMg9H0tDk31fO2Mk2m3u58J1zOQeAHxiNMRLZuV67rvHanhM-ZmPKxRcwwoLQJM3E6isYIZTiROQ5PQRH3j9uT8zpN3CYIo5FyukI_L21TV8H1Zqu93BqgnGNbVWwXQu7Ci6tU9oE1UDVltAGD2dd7-BVs-mdDdZ4WLzCm2UyXy4m8J8Na3j_8Oaitw4n4KBStTffd_sY3M0u7ybzZHH9-2pysUg0ITzEqYRBCFNiRKkx51zgkpWk0qlIVRmjpoYYxIRCmlOe6bwoqlSrQlS6YiI7BmeD7cZ1z73xQTbWa1PXQyrJKInJCckjiQdSu857Zyq5cbZR7lViJLeVyn2lknDJZKw0ak537n3RmPJdse8wAj93gPJa1ZVTrbb-g8sQFTkjkfs1cF2_-dTfZMCtD-blXaDck8xZxqicr_7IiVgSPBWr-OU_3gmfbA</recordid><startdate>20100801</startdate><enddate>20100801</enddate><creator>Arayne, M. Saeed</creator><creator>Sultana, Najma</creator><creator>Siddiqui, Farhan Ahmed</creator><creator>Mirza, Agha Zeeshan</creator><creator>Qureshi, Faiza</creator><creator>Zuberi, M. Hashim</creator><general>Oxford University Press</general><general>Preston Publications</general><scope>BSCLL</scope><scope>IQODW</scope><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></search><sort><creationdate>20100801</creationdate><title>Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection</title><author>Arayne, M. Saeed ; Sultana, Najma ; Siddiqui, Farhan Ahmed ; Mirza, Agha Zeeshan ; Qureshi, Faiza ; Zuberi, M. Hashim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c448t-c4a9e00154e9dc188891d7d4fc292ad1092e4e079a0c8583c6bbf2cab9fcf793</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Acetic Acid - analysis</topic><topic>Acetic Acid - chemistry</topic><topic>Analysis</topic><topic>Biological and medical sciences</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Chromatography, Reverse-Phase - methods</topic><topic>Drug Contamination</topic><topic>Drug Stability</topic><topic>General pharmacology</topic><topic>Hydrogen-Ion Concentration</topic><topic>Linear Models</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Piracetam - analysis</topic><topic>Piracetam - chemistry</topic><topic>Pyrrolidinones - analysis</topic><topic>Pyrrolidinones - chemistry</topic><topic>Reproducibility of Results</topic><topic>Spectrophotometry, Ultraviolet</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Arayne, M. Saeed</creatorcontrib><creatorcontrib>Sultana, Najma</creatorcontrib><creatorcontrib>Siddiqui, Farhan Ahmed</creatorcontrib><creatorcontrib>Mirza, Agha Zeeshan</creatorcontrib><creatorcontrib>Qureshi, Faiza</creatorcontrib><creatorcontrib>Zuberi, M. 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Hashim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection</atitle><jtitle>Journal of chromatographic science</jtitle><stitle>Journal of Chromatographic Science</stitle><addtitle>Journal of Chromatographic Science</addtitle><date>2010-08-01</date><risdate>2010</risdate><volume>48</volume><issue>7</issue><spage>589</spage><epage>594</epage><pages>589-594</pages><issn>0021-9665</issn><eissn>1945-239X</eissn><coden>JCHSBZ</coden><abstract>A simple and rapid high-performance liquid chromatographic method for the separation and determination of piracetam and its four impurities, 2-oxopyrrolidin-1-yl)acetic acid, pyrrolidin-2-one, methyl (2-oxopyrrolidin-1-yl)acetate, and ethyl (2-oxopyrrolidin-1-yl)acetate, was developed. The separation was achieved on a reversed-phase C18 Nucleosil column (25 cm × 0.46 cm, 10 μm). The mobile phase is composed of an aqueous solution containing 0.2 g/L of triethyl amine.acetonitrile (85:15, v/v). The pH of the mobile phase was adjusted to 6.5 with phosphoric acid at a flow rate of 1 mL/min at ambient temperature and UV detection at 205 nm. The developed method was found to give good separation between the pure drug and its four related substance. The polynomial regression data for the calibration plots showed good linear relationship in the concentration range of 50.10,000 ng/mL, 25.10,000 ng/mL, 45.10,000 ng/mL, 34.10,000 ng/mL, and 55.10,000 ng/mL, respectively, with r2 = 0.9999. The method was validated for precision, accuracy, ruggedness, and recovery. The minimum quantifiable amounts were found to be 50 ng/mL of piracetam, 25 ng/mL of 2-oxopyrrolidin-1-yl)acetic acid, 45 ng/mL of pyrrolidin-2-one, 34 ng/mL of methyl (2-oxopyrrolidin-1-yl)acetate, and 55 ng/mL of ethyl (2-oxopyrrolidin-1-yl)acetate. Statistical analysis proves that the method is reproducible and selective for the estimation of piracetam as well as its related substance. As the method could effectively separate the drug from the related substances, it can be employed as a stability-indicating one. The proposed method shows high efficiency, allowing the separation of the main component piracetam from other impurities.</abstract><cop>Niles, IL</cop><pub>Oxford University Press</pub><pmid>20819285</pmid><doi>10.1093/chromsci/48.7.589</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Acetic Acid - analysis Acetic Acid - chemistry Analysis Biological and medical sciences Chromatography, High Pressure Liquid - methods Chromatography, Reverse-Phase - methods Drug Contamination Drug Stability General pharmacology Hydrogen-Ion Concentration Linear Models Medical sciences Pharmacology. Drug treatments Piracetam - analysis Piracetam - chemistry Pyrrolidinones - analysis Pyrrolidinones - chemistry Reproducibility of Results Spectrophotometry, Ultraviolet |
title | Simultaneous Determination of Piracetam and its Four Impurities by RP-HPLC with UV Detection |
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