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<article xlink="http://www.w3.org/1999/xlink" dtd-version="1.0" article-type="healthcare" lang="en"><front><journal-meta><journal-id journal-id-type="publisher">IJCRR</journal-id><journal-id journal-id-type="nlm-ta">I Journ Cur Res Re</journal-id><journal-title-group><journal-title>International Journal of Current Research and Review</journal-title><abbrev-journal-title abbrev-type="pubmed">I Journ Cur Res Re</abbrev-journal-title></journal-title-group><issn pub-type="ppub">2231-2196</issn><issn pub-type="opub">0975-5241</issn><publisher><publisher-name>Radiance Research Academy</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">4308</article-id><article-id pub-id-type="doi"/><article-id pub-id-type="doi-url">http://dx.doi.org/10.31782/IJCRR.2021.14106</article-id><article-categories><subj-group subj-group-type="heading"><subject>Healthcare</subject></subj-group></article-categories><title-group><article-title>Identification of the Organic Volatile Impurities in Telmisartan Active Pharmaceutical Ingredient and Its Pharmaceutical dosage forms by using Head Space Gas Chromatography Technique__ampersandsignnbsp;&#13;
</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Kishore</surname><given-names>J. Krishna</given-names></name></contrib><contrib contrib-type="author"><name><surname>Rao</surname><given-names>K. Prasada</given-names></name></contrib></contrib-group><pub-date pub-type="ppub"><day>3</day><month>01</month><year>2022</year></pub-date><volume>)</volume><issue/><fpage>124</fpage><lpage>131</lpage><permissions><copyright-statement>This article is copyright of Popeye Publishing, 2009</copyright-statement><copyright-year>2009</copyright-year><license license-type="open-access" href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence, and indicate if changes were made.</license-p></license></permissions><abstract><p>Introduction: Residual Solvents or Organic Volatile Impurities are potential risk for quality and stability of drug products as well as human body if intake exceeds the permitted daily exposure. They do not provide any therapeutic benefit and must be removed to the maximum possible level Objective: The work presented in this paper explains the simple and rapid Head Space Gas Chromatography (HS-GC) technique for the Quantitative estimation of Three Organic Volatile Impurities (OVIs) in Telmisartan Active Pharmaceutical Ingredient (API) and its Pharmaceutical dosage forms. Methods: Organic solvents such as methanol, acetone, and n-butanol are frequently used in the manufacturing of Telmisartan. The process for quantification of OVIs in Telmisartan API has been done with Head Space Gas Chromatographic method with detector of Flame Ionization and utilizing the Shimadzu GC- 2010 with a capillary column of FID (DB-624, 30 m __ampersandsigntimes; 0.53 mm, 3 __ampersandsignmu;), with a carrier gas nitrogen at 4.0 mL/min flow rate. The experimental parameters like injection temperature, oven temperature, make-up flow, zero air, injection temperature; split ratio, headspace conditions, and the diluent selection have been considered and were optimized. Results: Retention times are 2.23 min for methanol, 3.04 min for acetone, and 7.20 min for n-butanol respectively. The proposed technique has been statistically validated based on standard International Conference on Harmonization guidelines (ICH). The % Relative Standard Deviation (% RSD) for the system precision of six injections was should be not more than 10.0 %. The percentage recovery was found between 85-115 %. The correlation coefficient (R2) is not less than 0.99. Limit of Detection (LOD) was found as 19 ppm (methanol), 26 ppm (acetone), and 21 ppm (n-butanol). The Limit of Quantification (LOQ) was found as 58 ppm (methanol), 77 ppm (acetone), and 64 ppm for n-butanol. The intermediate precision and method precision were found to be within the limit of acceptance. Conclusion: From the obtained validation results the proposed technique has been fruitfully applied for quantification of organic volatile impurities in Telmisartan Active Pharmaceutical Ingredient as well as its pharmaceutical dosage forms.&#13;
</p></abstract><kwd-group><kwd>Method development</kwd><kwd> Organic volatile impurities</kwd><kwd> Telmisartan API</kwd><kwd> Validation</kwd><kwd> Chromatography</kwd><kwd> Quantification</kwd></kwd-group></article-meta></front></article>
