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Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations
A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containin...
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| Published in: | Journal of pharmaceutical and biomedical analysis 2011-11, Vol.56 (3), p.471-478 |
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| Main Authors: | , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c409t-e48e7aa669255776d9d62a082556276bd98f09738ab97063d07220ce6ca869143 |
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| cites | cdi_FETCH-LOGICAL-c409t-e48e7aa669255776d9d62a082556276bd98f09738ab97063d07220ce6ca869143 |
| container_end_page | 478 |
| container_issue | 3 |
| container_start_page | 471 |
| container_title | Journal of pharmaceutical and biomedical analysis |
| container_volume | 56 |
| creator | Nageswara Rao, R. Guru Prasad, K. Gangu Naidu, Ch Maurya, Pawan K. |
| description | A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containing 0.1% (v/v) triethylamine (pH adjusted to 3.0 with trifluoroacetic acid) and acetonitrile as mobile phase at 25°C. The detection was performed at 254nm. The method was validated and found to be robust, precise, specific and linear between 0.37 and 500μg/mL. The limits of detection and quantification of telmisartan were 0.11 and 0.37μg/mL, respectively. The method was successfully applied to quantify related substances and assay of TLM in bulk drugs and commercial tablets. The related substances relate to a novel synthetic route and different from those A-H impurities reported by European Pharmacopeia. |
| doi_str_mv | 10.1016/j.jpba.2011.05.043 |
| format | article |
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The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containing 0.1% (v/v) triethylamine (pH adjusted to 3.0 with trifluoroacetic acid) and acetonitrile as mobile phase at 25°C. The detection was performed at 254nm. The method was validated and found to be robust, precise, specific and linear between 0.37 and 500μg/mL. The limits of detection and quantification of telmisartan were 0.11 and 0.37μg/mL, respectively. The method was successfully applied to quantify related substances and assay of TLM in bulk drugs and commercial tablets. The related substances relate to a novel synthetic route and different from those A-H impurities reported by European Pharmacopeia.</description><identifier>ISSN: 0731-7085</identifier><identifier>EISSN: 1873-264X</identifier><identifier>DOI: 10.1016/j.jpba.2011.05.043</identifier><identifier>PMID: 21719227</identifier><identifier>CODEN: JPBADA</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>acetonitrile ; Acetonitriles - analysis ; Acetonitriles - chemistry ; ammonium acetate ; Analysis ; Analytical, structural and metabolic biochemistry ; Benzimidazoles - analysis ; Benzimidazoles - chemistry ; Benzoates - analysis ; Benzoates - chemistry ; Biological and medical sciences ; Bulk drugs ; Chemistry, Pharmaceutical - methods ; Chromatography, Liquid - methods ; detection limit ; Drug Contamination ; Ethylamines - analysis ; Ethylamines - chemistry ; Fundamental and applied biological sciences. Psychology ; General pharmacology ; Hypertension ; Medical sciences ; Pharmacology. Drug treatments ; Quality Control ; Related substances ; Reproducibility of Results ; reversed-phase liquid chromatography ; RP-HPLC ; Tablets - analysis ; Tablets - chemistry ; Telmisartan ; triethylamine</subject><ispartof>Journal of pharmaceutical and biomedical analysis, 2011-11, Vol.56 (3), p.471-478</ispartof><rights>2011 Elsevier B.V.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-e48e7aa669255776d9d62a082556276bd98f09738ab97063d07220ce6ca869143</citedby><cites>FETCH-LOGICAL-c409t-e48e7aa669255776d9d62a082556276bd98f09738ab97063d07220ce6ca869143</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24472969$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21719227$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nageswara Rao, R.</creatorcontrib><creatorcontrib>Guru Prasad, K.</creatorcontrib><creatorcontrib>Gangu Naidu, Ch</creatorcontrib><creatorcontrib>Maurya, Pawan K.</creatorcontrib><title>Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations</title><title>Journal of pharmaceutical and biomedical analysis</title><addtitle>J Pharm Biomed Anal</addtitle><description>A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containing 0.1% (v/v) triethylamine (pH adjusted to 3.0 with trifluoroacetic acid) and acetonitrile as mobile phase at 25°C. The detection was performed at 254nm. The method was validated and found to be robust, precise, specific and linear between 0.37 and 500μg/mL. The limits of detection and quantification of telmisartan were 0.11 and 0.37μg/mL, respectively. The method was successfully applied to quantify related substances and assay of TLM in bulk drugs and commercial tablets. The related substances relate to a novel synthetic route and different from those A-H impurities reported by European Pharmacopeia.</description><subject>acetonitrile</subject><subject>Acetonitriles - analysis</subject><subject>Acetonitriles - chemistry</subject><subject>ammonium acetate</subject><subject>Analysis</subject><subject>Analytical, structural and metabolic biochemistry</subject><subject>Benzimidazoles - analysis</subject><subject>Benzimidazoles - chemistry</subject><subject>Benzoates - analysis</subject><subject>Benzoates - chemistry</subject><subject>Biological and medical sciences</subject><subject>Bulk drugs</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Chromatography, Liquid - methods</subject><subject>detection limit</subject><subject>Drug Contamination</subject><subject>Ethylamines - analysis</subject><subject>Ethylamines - chemistry</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>General pharmacology</subject><subject>Hypertension</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Quality Control</subject><subject>Related substances</subject><subject>Reproducibility of Results</subject><subject>reversed-phase liquid chromatography</subject><subject>RP-HPLC</subject><subject>Tablets - analysis</subject><subject>Tablets - chemistry</subject><subject>Telmisartan</subject><subject>triethylamine</subject><issn>0731-7085</issn><issn>1873-264X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><recordid>eNp9kc2O1DAQhCMEYmcXXoAD-II4zdB2EjuWuKwWFpBW4gArcbMcuzPjwYlnbWckXoJnxvMD3DhZ3fqq3KqqqhcUVhQof7tdbXe9XjGgdAXtCpr6UbWgnaiXjDffH1cLEDVdCujai-oypS0AtFQ2T6sLRgWVjIlF9es97tGH3YhTJmEgmuy1d1ZntMS7h9lZYjYxjDqHddS7jTNkxLwJlgwhEosZ4-gmnV2YDvKI_ihNc5-yngymwzajH13SsWyIm0g_-x_ExnmdiJ6ORuPsjxbpWfVk0D7h8_N7Vd3ffvh282l59-Xj55vru6VpQOYlNh0KrTmXrG2F4FZazjR0ZeJM8N7KbgAp6k73UgCvLQjGwCA3uuOSNvVV9ebku4vhYcaUVTnQoPd6wjAn1XWMFiPGC8lOpIkhpYiD2kU36vhTUVCHGtRWHWpQhxoUtKrUUEQvz_ZzP6L9K_mTewFenwGdjPZDLFm59I9rGsEkl4V7deIGHZRex8Lcfy0_tQCUgaBQiHcnAktce4dRJeOwJG9dRJOVDe5_l_4GAC2xTQ</recordid><startdate>20111101</startdate><enddate>20111101</enddate><creator>Nageswara Rao, R.</creator><creator>Guru Prasad, K.</creator><creator>Gangu Naidu, Ch</creator><creator>Maurya, Pawan K.</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>FBQ</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>20111101</creationdate><title>Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations</title><author>Nageswara Rao, R. ; Guru Prasad, K. ; Gangu Naidu, Ch ; Maurya, Pawan K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-e48e7aa669255776d9d62a082556276bd98f09738ab97063d07220ce6ca869143</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>acetonitrile</topic><topic>Acetonitriles - analysis</topic><topic>Acetonitriles - chemistry</topic><topic>ammonium acetate</topic><topic>Analysis</topic><topic>Analytical, structural and metabolic biochemistry</topic><topic>Benzimidazoles - analysis</topic><topic>Benzimidazoles - chemistry</topic><topic>Benzoates - analysis</topic><topic>Benzoates - chemistry</topic><topic>Biological and medical sciences</topic><topic>Bulk drugs</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Chromatography, Liquid - methods</topic><topic>detection limit</topic><topic>Drug Contamination</topic><topic>Ethylamines - analysis</topic><topic>Ethylamines - chemistry</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>General pharmacology</topic><topic>Hypertension</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Quality Control</topic><topic>Related substances</topic><topic>Reproducibility of Results</topic><topic>reversed-phase liquid chromatography</topic><topic>RP-HPLC</topic><topic>Tablets - analysis</topic><topic>Tablets - chemistry</topic><topic>Telmisartan</topic><topic>triethylamine</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nageswara Rao, R.</creatorcontrib><creatorcontrib>Guru Prasad, K.</creatorcontrib><creatorcontrib>Gangu Naidu, Ch</creatorcontrib><creatorcontrib>Maurya, Pawan K.</creatorcontrib><collection>AGRIS</collection><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 pharmaceutical and biomedical analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nageswara Rao, R.</au><au>Guru Prasad, K.</au><au>Gangu Naidu, Ch</au><au>Maurya, Pawan K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations</atitle><jtitle>Journal of pharmaceutical and biomedical analysis</jtitle><addtitle>J Pharm Biomed Anal</addtitle><date>2011-11-01</date><risdate>2011</risdate><volume>56</volume><issue>3</issue><spage>471</spage><epage>478</epage><pages>471-478</pages><issn>0731-7085</issn><eissn>1873-264X</eissn><coden>JPBADA</coden><abstract>A simple and rapid reversed phase liquid chromatographic method for separation and determination of the related substances of telmisartan (TLM) was developed and validated. The chromatographic separation was achieved on Lichrospher RP-18 column (250×4.6mm, 5μm), using 20mM ammonium acetate containing 0.1% (v/v) triethylamine (pH adjusted to 3.0 with trifluoroacetic acid) and acetonitrile as mobile phase at 25°C. The detection was performed at 254nm. The method was validated and found to be robust, precise, specific and linear between 0.37 and 500μg/mL. The limits of detection and quantification of telmisartan were 0.11 and 0.37μg/mL, respectively. The method was successfully applied to quantify related substances and assay of TLM in bulk drugs and commercial tablets. The related substances relate to a novel synthetic route and different from those A-H impurities reported by European Pharmacopeia.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>21719227</pmid><doi>10.1016/j.jpba.2011.05.043</doi><tpages>8</tpages></addata></record> |
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| ispartof | Journal of pharmaceutical and biomedical analysis, 2011-11, Vol.56 (3), p.471-478 |
| issn | 0731-7085 1873-264X |
| language | eng |
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| source | ScienceDirect Journals |
| subjects | acetonitrile Acetonitriles - analysis Acetonitriles - chemistry ammonium acetate Analysis Analytical, structural and metabolic biochemistry Benzimidazoles - analysis Benzimidazoles - chemistry Benzoates - analysis Benzoates - chemistry Biological and medical sciences Bulk drugs Chemistry, Pharmaceutical - methods Chromatography, Liquid - methods detection limit Drug Contamination Ethylamines - analysis Ethylamines - chemistry Fundamental and applied biological sciences. Psychology General pharmacology Hypertension Medical sciences Pharmacology. Drug treatments Quality Control Related substances Reproducibility of Results reversed-phase liquid chromatography RP-HPLC Tablets - analysis Tablets - chemistry Telmisartan triethylamine |
| title | Development of a validated liquid chromatographic method for determination of related substances of telmisartan in bulk drugs and formulations |
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