Development and Validation of a Stability-Indicating LC Method for the Assay of Lodenafil Carbonate in Tablets
A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 µm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1...
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| Veröffentlicht in: | Journal of chromatographic science 2011-08, Vol.49 (7), p.502-507 |
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| container_title | Journal of chromatographic science |
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| creator | Bergold, Ana Maria Codevilla, Cristiane Franco Lemos, Alice Machado Delgado, Leila Schreiner Rolim, Clarice Madalena Bueno Adams, Andréa Inês Horn |
| description | A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 µm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1 % pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 µg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD < 2.0%). Validation parameters as specificity and robustness were also determined. Specificity analysis showed that no impurities or degradation products were co-eluting with the lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets. |
| doi_str_mv | 10.1093/chrsci/49.7.502 |
| format | Article |
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The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 µm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1 % pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 µg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD < 2.0%). Validation parameters as specificity and robustness were also determined. Specificity analysis showed that no impurities or degradation products were co-eluting with the lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets.</description><identifier>ISSN: 0021-9665</identifier><identifier>EISSN: 1945-239X</identifier><identifier>DOI: 10.1093/chrsci/49.7.502</identifier><identifier>PMID: 21801480</identifier><identifier>CODEN: JCHSBZ</identifier><language>eng</language><publisher>Niles, IL: Oxford University Press</publisher><subject>Analysis ; Analytical chemistry ; Biological and medical sciences ; Carbonates - chemistry ; Chemistry ; Chromatographic methods and physical methods associated with chromatography ; Chromatography, High Pressure Liquid - methods ; Drug Stability ; Exact sciences and technology ; General pharmacology ; Medical sciences ; Other chromatographic methods ; Pharmacology. Drug treatments ; Piperazines - chemistry ; Pyrimidines - chemistry ; Tablets - chemistry</subject><ispartof>Journal of chromatographic science, 2011-08, Vol.49 (7), p.502-507</ispartof><rights>2011</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c402t-4d72c367b91fe3f519577f88831dd7aee01d72d7f30b420699843cb66b905ff83</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=24358090$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21801480$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bergold, Ana Maria</creatorcontrib><creatorcontrib>Codevilla, Cristiane Franco</creatorcontrib><creatorcontrib>Lemos, Alice Machado</creatorcontrib><creatorcontrib>Delgado, Leila Schreiner</creatorcontrib><creatorcontrib>Rolim, Clarice Madalena Bueno</creatorcontrib><creatorcontrib>Adams, Andréa Inês Horn</creatorcontrib><title>Development and Validation of a Stability-Indicating LC Method for the Assay of Lodenafil Carbonate in Tablets</title><title>Journal of chromatographic science</title><addtitle>Journal of Chromatographic Science</addtitle><addtitle>J Chromatogr Sci</addtitle><description>A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 µm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1 % pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 µg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD < 2.0%). Validation parameters as specificity and robustness were also determined. Specificity analysis showed that no impurities or degradation products were co-eluting with the lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets.</description><subject>Analysis</subject><subject>Analytical chemistry</subject><subject>Biological and medical sciences</subject><subject>Carbonates - chemistry</subject><subject>Chemistry</subject><subject>Chromatographic methods and physical methods associated with chromatography</subject><subject>Chromatography, High Pressure Liquid - methods</subject><subject>Drug Stability</subject><subject>Exact sciences and technology</subject><subject>General pharmacology</subject><subject>Medical sciences</subject><subject>Other chromatographic methods</subject><subject>Pharmacology. Drug treatments</subject><subject>Piperazines - chemistry</subject><subject>Pyrimidines - chemistry</subject><subject>Tablets - chemistry</subject><issn>0021-9665</issn><issn>1945-239X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqF0MtrGzEQB2ARGhLncc6t6FIKgbWllXYlHYP7Crj00KT0JrR61Aqy5EhywP99d7HbHHMahvlmBn4A3GA0x0iQhV7nov2Cijmbd6g9ATMsaNe0RPx-B2YItbgRfd-dg4tSnqYW8-4MnLeYI0w5moH4yb7YkLYbGytU0cBfKnijqk8RJgcV_FnV4IOv--Y-Gq_HSfwDV0v43dZ1MtClDOvawrtS1H7aWCVjo3I-wKXKQ4qqWugjfFBDsLVcgVOnQrHXx3oJHr98flh-a1Y_vt4v71aNpqitDTWs1aRng8DOEtdh0THmOOcEG8OUtQiPwjBH0EBb1AvBKdFD3w8Cdc5xcgk-Hu5uc3re2VLlxhdtQ1DRpl2RnCOGmWgnuThInVMp2Tq5zX6j8l5iJKeM5SFjSYVkcsx43Hh_vL0bNtb89_9CHcGHI1BFq-CyitqXV0dJx5GY3O3Bpd32za9_AS5qk3M</recordid><startdate>20110801</startdate><enddate>20110801</enddate><creator>Bergold, Ana Maria</creator><creator>Codevilla, Cristiane Franco</creator><creator>Lemos, Alice Machado</creator><creator>Delgado, Leila Schreiner</creator><creator>Rolim, Clarice Madalena Bueno</creator><creator>Adams, Andréa Inês Horn</creator><general>Oxford University Press</general><general>Preston Publications</general><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>20110801</creationdate><title>Development and Validation of a Stability-Indicating LC Method for the Assay of Lodenafil Carbonate in Tablets</title><author>Bergold, Ana Maria ; Codevilla, Cristiane Franco ; Lemos, Alice Machado ; Delgado, Leila Schreiner ; Rolim, Clarice Madalena Bueno ; Adams, Andréa Inês Horn</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c402t-4d72c367b91fe3f519577f88831dd7aee01d72d7f30b420699843cb66b905ff83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Analysis</topic><topic>Analytical chemistry</topic><topic>Biological and medical sciences</topic><topic>Carbonates - chemistry</topic><topic>Chemistry</topic><topic>Chromatographic methods and physical methods associated with chromatography</topic><topic>Chromatography, High Pressure Liquid - methods</topic><topic>Drug Stability</topic><topic>Exact sciences and technology</topic><topic>General pharmacology</topic><topic>Medical sciences</topic><topic>Other chromatographic methods</topic><topic>Pharmacology. Drug treatments</topic><topic>Piperazines - chemistry</topic><topic>Pyrimidines - chemistry</topic><topic>Tablets - chemistry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bergold, Ana Maria</creatorcontrib><creatorcontrib>Codevilla, Cristiane Franco</creatorcontrib><creatorcontrib>Lemos, Alice Machado</creatorcontrib><creatorcontrib>Delgado, Leila Schreiner</creatorcontrib><creatorcontrib>Rolim, Clarice Madalena Bueno</creatorcontrib><creatorcontrib>Adams, Andréa Inês Horn</creatorcontrib><collection>Pascal-Francis</collection><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>Journal of chromatographic science</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bergold, Ana Maria</au><au>Codevilla, Cristiane Franco</au><au>Lemos, Alice Machado</au><au>Delgado, Leila Schreiner</au><au>Rolim, Clarice Madalena Bueno</au><au>Adams, Andréa Inês Horn</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and Validation of a Stability-Indicating LC Method for the Assay of Lodenafil Carbonate in Tablets</atitle><jtitle>Journal of chromatographic science</jtitle><stitle>Journal of Chromatographic Science</stitle><addtitle>J Chromatogr Sci</addtitle><date>2011-08-01</date><risdate>2011</risdate><volume>49</volume><issue>7</issue><spage>502</spage><epage>507</epage><pages>502-507</pages><issn>0021-9665</issn><eissn>1945-239X</eissn><coden>JCHSBZ</coden><abstract>A stability-indicating liquid chromatographic method has been developed for the quantitative determination of lodenafil carbonate in tablets. The method employs a Synergi Fusion C18 column (250 × 4.6 mm, i.d., 4 µm particle size), with mobile phase consisting of a mixture of methanol-acetic acid 0.1 % pH 4.0 (65:35, v/v) and UV detection at 290 nm, using a photodiode array detector. A linear response (r = 0.9999) was observed in the range of 10-80 µg/mL. The method showed good recoveries (average 100.3%) and also intra and inter-day precision (RSD < 2.0%). Validation parameters as specificity and robustness were also determined. Specificity analysis showed that no impurities or degradation products were co-eluting with the lodenafil carbonate peak. The method was found to be stability-indicating and due to its simplicity and accuracy can be applied for routine quality control analysis of lodenafil carbonate in tablets.</abstract><cop>Niles, IL</cop><pub>Oxford University Press</pub><pmid>21801480</pmid><doi>10.1093/chrsci/49.7.502</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); EZB-FREE-00999 freely available EZB journals; Free Full-Text Journals in Chemistry |
| subjects | Analysis Analytical chemistry Biological and medical sciences Carbonates - chemistry Chemistry Chromatographic methods and physical methods associated with chromatography Chromatography, High Pressure Liquid - methods Drug Stability Exact sciences and technology General pharmacology Medical sciences Other chromatographic methods Pharmacology. Drug treatments Piperazines - chemistry Pyrimidines - chemistry Tablets - chemistry |
| title | Development and Validation of a Stability-Indicating LC Method for the Assay of Lodenafil Carbonate in Tablets |
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