{"id":14223,"date":"2025-10-14T21:36:32","date_gmt":"2025-10-14T14:36:32","guid":{"rendered":"https:\/\/nhathuocngocanh.com\/bp\/?p=14223"},"modified":"2025-10-14T21:38:46","modified_gmt":"2025-10-14T14:38:46","slug":"felbinac-gel","status":"publish","type":"post","link":"https:\/\/nhathuocngocanh.com\/bp\/felbinac-gel\/","title":{"rendered":"Felbinac Gel"},"content":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update)<\/p>\n<p><strong>Action and use<\/strong><\/p>\n<p>Cyclo-oxygenase inhibitor; analgesic; antinflammatory.<\/p>\n<h2>DEFINITION<\/h2>\n<p>Felbinac Gel is a solution of Felbinac in a suitable water-miscible basis.<\/p>\n<p>The gel complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements.<\/p>\n<p>Content of felbinac, C<sub>14<\/sub>H<sub>12<\/sub>O<sub>2<\/sub><\/p>\n<p>95.0 to 105.0% of the stated amount.<\/p>\n<h2>IDENTIFICATION<\/h2>\n<p>A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.<\/p>\n<p>(1) Dilute a quantity of the gel containing 30 mg of Felbinac with sufficient acetone to produce 5 mL and mix.<br \/>\n(2) 0.6% w\/v solution of felbinac BPCRS in acetone.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use as the coating silica gel F254 (Merck silica gel 60 F254 plates are suitable).<br \/>\n(b) Use the mobile phase as described below.<br \/>\n(c) Apply 5 \u03bcL of each solution.<br \/>\n(d) Develop the plate to 12 cm.<br \/>\n(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm) (first examination). Spray the plate with a mixture of equal volumes of formaldehyde solution and sulfuric acid and heat at 110\u00b0 for 10 minutes (second examination).<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>1 volume of glacial acetic acid, 25 volumes of acetone and 50 volumes of hexane.<\/p>\n<h3>CONFIRMATION<\/h3>\n<p>In the first examination:<br \/>\nThe principal spot in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2).<br \/>\nIn the second examination:<br \/>\nThe principal spots in the chromatograms obtained with solutions (1) and (2) are an intense purple colour.<br \/>\nB. In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).<\/p>\n<h2>TESTS<\/h2>\n<p><strong>Acidity or alkalinity<\/strong><br \/>\npH, 7.0 to 8.0, Appendix V L.<\/p>\n<p><strong>Related substances<\/strong><\/p>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dissolve a weighed quantity of the gel containing 30 mg of Felbinac in methanol and add sufficient methanol to produce 50 mL.<br \/>\n(2) Dilute 1 volume of solution (1) to 100 volumes with mobile phase and further dilute 1 volume of this solution to 10 volumes with the same solvent.<br \/>\n(3) 0.00006% w\/v of 4-acetylbiphenyl and 0.00006% w\/v of biphenyl in methanol<br \/>\n(4) 0.001% w\/v of felbinac BPCRS and 0.001% w\/v of o-phenylbenzoic acid in mobile phase.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>(a) Use a stainless steel column (10 cm \u00d7 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (10 \u03bcm) (Partisil ODS3 is suitable).<br \/>\n(b) Use isocratic elution and the mobile phase described below.<br \/>\n(c) Use a flow rate of 2 mL per minute.<br \/>\n(d) Use an ambient column temperature.<br \/>\n(e) Use a detection wavelength of 254 nm.<br \/>\n(f) Inject 50 \u03bcL of each solution.<br \/>\n(g) For solution (1) allow the chromatography to proceed for at least twice the retention time of the principal peak.<\/p>\n<h3>MOBILE PHASE<\/h3>\n<p>45 volumes of a 0.1% v\/v solution of glacial acetic acid and 55 volumes of methanol.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The test is not valid unless, in the chromatogram obtained with solution (4), the resolution between the two principal peaks is at least 3.0.<\/p>\n<h3>LIMITS<\/h3>\n<p>In the chromatogram obtained with solution (1):<\/p>\n<p>the area of any peak corresponding to 4-acetylbiphenyl is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.1%);<\/p>\n<p>the area of any peak corresponding to biphenyl is not greater than the area of the corresponding peak in the chromatogram obtained with solution (3) (0.1%);<\/p>\n<p>the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).<\/p>\n<h2>ASSAY<\/h2>\n<p>Carry out the method for liquid chromatography, Appendix III D, using the following solutions.<\/p>\n<p>(1) Dissolve a quantity of the gel containing 30 mg of Felbinac in 70 mL of mobile phase, add sufficient mobile phase to produce 100 mL, mix and dilute 1 volume of the resulting solution to 20 volumes with mobile phase.<br \/>\n(2) 0.0015% w\/v of felbinac BPCRS in mobile phase.<br \/>\n(3) 0.0015% w\/v of felbinac BPCRS and 0.0015% w\/v of o-phenylbenzoic acid in mobile phase.<\/p>\n<h3>CHROMATOGRAPHIC CONDITIONS<\/h3>\n<p>Use the chromatographic conditions described under Related substances, with the exception of the run time. Inject 20 \u03bcL of each solution.<\/p>\n<h3>SYSTEM SUITABILITY<\/h3>\n<p>The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution between the two principal peaks is at least 3.0.<\/p>\n<h3>DETERMINATION OF CONTENT<\/h3>\n<p>Calculate the content of C<sub>14<\/sub>H<sub>12<\/sub>O<sub>2<\/sub> in the gel from the chromatograms obtained using the declared content of C<sub>14<\/sub>H<sub>12<\/sub>O<sub>2 <\/sub>in felbinac BPCRS.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Edition: BP 2025 (Ph. Eur. 11.6 update) Action and use Cyclo-oxygenase inhibitor; analgesic; antinflammatory. DEFINITION Felbinac Gel is a solution of Felbinac in a suitable water-miscible basis. The gel complies with the requirements stated under Topical Semi-solid Preparations and with the following requirements. Content of felbinac, C14H12O2 95.0 to 105.0% of the stated amount. IDENTIFICATION&#8230;<\/p>\n","protected":false},"author":5,"featured_media":14225,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[175],"tags":[],"class_list":["post-14223","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-formulated-preparations-specific-monographs"],"acf":[],"_links":{"self":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14223","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/comments?post=14223"}],"version-history":[{"count":4,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14223\/revisions"}],"predecessor-version":[{"id":14230,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/posts\/14223\/revisions\/14230"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media\/14225"}],"wp:attachment":[{"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/media?parent=14223"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/categories?post=14223"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/nhathuocngocanh.com\/bp\/wp-json\/wp\/v2\/tags?post=14223"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}